<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02203591</url>
  </required_header>
  <id_info>
    <org_study_id>EM-013260</org_study_id>
    <nct_id>NCT02203591</nct_id>
  </id_info>
  <brief_title>In Vivo Efficacy Study of Patient Preoperative Preps</brief_title>
  <official_title>Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>3M</source>
  <brief_summary>
    <textblock>
      The objective of this study is to demonstrate the antimicrobial efficacy of the 3M CHG/IPA&#xD;
      Prep on skin flora of the abdominal and inguinal regions of human subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary efficacy is evaluated by demonstration that the product provides a lower bound of&#xD;
      the 95% confidence interval of percent responders that is greater than or equal to 70% On the&#xD;
      abdominal site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at&#xD;
      10 minutes and for whom the skin flora does not return to baseline at 6 hours.&#xD;
&#xD;
      On the inguinal site, a responder is defined as a subject with a 3-log10/cm2 bacterial&#xD;
      reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Responder Rate</measure>
    <time_frame>baseline, 10 minutes post-product application and 6 hours post-product application</time_frame>
    <description>On the abdominal region a responder is a subject with a 2 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.&#xD;
On the inguinal region a responder is a subject with a 3 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alternative Primary</measure>
    <time_frame>Baseline and 10 minutes</time_frame>
    <description>10 minute log reduction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of Skin Flora 6 Hours Post-treatment</measure>
    <time_frame>6 hours</time_frame>
    <description>Log10/cm^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of Skin Flora 10 Minutes Post-treatment</measure>
    <time_frame>10 minutes</time_frame>
    <description>Log10/cm^2 reduction of skin flora, relative to treatment day baseline (log10/cm^2) at 10 minutes post-treatment application</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Flora Recovery 6-hours Post-treatment</measure>
    <time_frame>6 hours post-treatment</time_frame>
    <description>Log10/cm^2 recovery of skin flora at 6 hours following application of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Flora Recovery 10 Minutes Post-treatment</measure>
    <time_frame>10 minute post-product application</time_frame>
    <description>Log10/cm^2 recovery of skin flora at 10 minutes following application of study treatments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Flora Baseline for the Abdomen and Inguinal Region.</measure>
    <time_frame>Baseline</time_frame>
    <description>Log10/cm^2 baseline skin flora for abdominal and inguinal regions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score</measure>
    <time_frame>Baseline</time_frame>
    <description>Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score</measure>
    <time_frame>10 minutes post-treatment</time_frame>
    <description>Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0=no reaction, 1=mild, 2=moderate, 3=severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety as Assessed by Skin Irritation Score</measure>
    <time_frame>6 hours post-treatment</time_frame>
    <description>Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">738</enrollment>
  <condition>Bacterial Reduction Post-product Application</condition>
  <arm_group>
    <arm_group_label>3M CHG/IPA Prep C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3M CHG/IPA Prep CH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ChloraPrep</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3M CHG/IPA Prep C</intervention_name>
    <description>Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.</description>
    <arm_group_label>3M CHG/IPA Prep C</arm_group_label>
    <other_name>Chlorhexidine Gluconate and Isopropyl Alcohol</other_name>
    <other_name>Chlorhexidine gluconate 2% / Isopropyl alcohol 70%</other_name>
    <other_name>CHG 2%/IPA 70%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3M CHG/IPA Prep CH</intervention_name>
    <description>Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.</description>
    <arm_group_label>3M CHG/IPA Prep CH</arm_group_label>
    <other_name>Chlorhexidine Gluconate and Isopropyl Alcohol</other_name>
    <other_name>Chlorhexidine gluconate 2% / Isopropyl alcohol 70%</other_name>
    <other_name>CHG 2%/IPA 70%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ChloraPrep</intervention_name>
    <description>Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.</description>
    <arm_group_label>ChloraPrep</arm_group_label>
    <other_name>ChloraPrep Patient Preoperative Skin Preparation</other_name>
    <other_name>ChloraPrep One-Step</other_name>
    <other_name>Chlorhexidine gluconate 2% / Isopropyl alcohol 70%</other_name>
    <other_name>CHG2%/IPA 70%</other_name>
    <other_name>Chlorhexidine Gluconate and Isopropyl Alcohol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.</description>
    <arm_group_label>Normal Saline</arm_group_label>
    <other_name>Sodium Chloride 0.9%</other_name>
    <other_name>Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects of any race&#xD;
&#xD;
          -  Subjects in good health&#xD;
&#xD;
          -  Minimum skin flora baseline requirements on abdomen and groin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin&#xD;
             disorders (including acne) on the applicable test area&#xD;
&#xD;
          -  Topical antimicrobial exposure within 14 days prior to screening and treatment days&#xD;
&#xD;
          -  Use of systemic or topical antibiotics, steroid medications, or any other products&#xD;
             known to affect the normal microbial flora of the skin within 14 days prior to&#xD;
             screening and treatment days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jamie Miller, ADN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Independent Consultant</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BioScience Laboratories, Inc.</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>March 6, 2019</results_first_submitted>
  <results_first_submitted_qc>October 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 23, 2020</results_first_posted>
  <disposition_first_submitted>March 25, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>March 25, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 26, 2015</disposition_first_posted>
  <last_update_submitted>October 30, 2020</last_update_submitted>
  <last_update_submitted_qc>October 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>surgical skin prep</keyword>
  <keyword>CHG</keyword>
  <keyword>IPA</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This is a randomized, paired comparison design where each subject received 2 of the planned treatments, 1 on the left side &amp; 1 on the right. Each subject provided 2 abdomen test sties, left &amp; right and/or 2 inguen test sites, left &amp; right.&#xD;
569 subjects were randomized for the abdomen region &amp; 404 subjects randomized for the inguen region resulting in 738 subjects providing 1946 applications of test products on 2 anatomical regions.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>3M CHG/IPA Prep C - Abdominal</title>
          <description>Applied topically to the abdominal region for 30 seconds.</description>
        </group>
        <group group_id="P2">
          <title>3M CHG/IPA Prep CH - Abdominal</title>
          <description>Applied topically to the abdominal region for 30 seconds.</description>
        </group>
        <group group_id="P3">
          <title>ChloraPrep - Abdominal</title>
          <description>Applied topically to the abdominal region for 30 seconds.</description>
        </group>
        <group group_id="P4">
          <title>Normal Saline - Abdominal</title>
          <description>Applied topically to the abdominal region for 30 seconds.</description>
        </group>
        <group group_id="P5">
          <title>3M CHG/IPA Prep C - Inguinal</title>
          <description>Applied topically to the inguinal region for 2 minutes.</description>
        </group>
        <group group_id="P6">
          <title>3M CHG/IPA Prep CH - Inguinal</title>
          <description>Applied topically to the inguinal region for 2 minutes.</description>
        </group>
        <group group_id="P7">
          <title>ChloraPrep - Inguinal</title>
          <description>Applied topically to the inguinal region for 2 minutes.</description>
        </group>
        <group group_id="P8">
          <title>Normal Saline - Inguinal</title>
          <description>Applied topically to the inguinal region for 2 minutes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="343"/>
                <participants group_id="P2" count="344"/>
                <participants group_id="P3" count="347"/>
                <participants group_id="P4" count="104"/>
                <participants group_id="P5" count="242"/>
                <participants group_id="P6" count="244"/>
                <participants group_id="P7" count="248"/>
                <participants group_id="P8" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="196"/>
                <participants group_id="P2" count="202"/>
                <participants group_id="P3" count="196"/>
                <participants group_id="P4" count="59"/>
                <participants group_id="P5" count="208"/>
                <participants group_id="P6" count="209"/>
                <participants group_id="P7" count="219"/>
                <participants group_id="P8" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="142"/>
                <participants group_id="P3" count="151"/>
                <participants group_id="P4" count="45"/>
                <participants group_id="P5" count="34"/>
                <participants group_id="P6" count="35"/>
                <participants group_id="P7" count="29"/>
                <participants group_id="P8" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not meet treatment day baseline</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="141"/>
                <participants group_id="P3" count="150"/>
                <participants group_id="P4" count="45"/>
                <participants group_id="P5" count="33"/>
                <participants group_id="P6" count="35"/>
                <participants group_id="P7" count="29"/>
                <participants group_id="P8" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinued early due to compromised test sites</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects with average screening day baseline counts of greater than or equal to 3.00 log10 CFU/cm2 bilaterally on the abdominal region and/or greater than or equal to 5.00 log10 CFU/cm2 bilaterally on the inguinal region were included in the analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>3M CHG/IPA Prep C - Abdominal</title>
          <description>Applied topically for 30 seconds to the abdominal test site</description>
        </group>
        <group group_id="B2">
          <title>3M CHG/IPA Prep CH - Abdominal</title>
          <description>Applied topically for 30 seconds to the abdominal test site</description>
        </group>
        <group group_id="B3">
          <title>ChloraPrep - Abdominal</title>
          <description>Applied topically for 30 seconds to the abdominal test site</description>
        </group>
        <group group_id="B4">
          <title>Saline - Abdominal</title>
          <description>Applied topically for 30 seconds to the abdominal test site</description>
        </group>
        <group group_id="B5">
          <title>3M CHG/IPA Prep C - Inguinal</title>
          <description>Applied topically for 2 minutes to the inguinal test site</description>
        </group>
        <group group_id="B6">
          <title>3M CHG/IPA Prep CH - Inguinal</title>
          <description>Applied topically for 2 minutes to the inguinal test site</description>
        </group>
        <group group_id="B7">
          <title>ChloraPrep - Inguinal</title>
          <description>Applied topically for 2 minutes to the inguinal test site</description>
        </group>
        <group group_id="B8">
          <title>Saline - Inguinal</title>
          <description>Applied topically for 2 minutes to the inguinal test site</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="343"/>
            <count group_id="B2" value="344"/>
            <count group_id="B3" value="347"/>
            <count group_id="B4" value="104"/>
            <count group_id="B5" value="242"/>
            <count group_id="B6" value="244"/>
            <count group_id="B7" value="248"/>
            <count group_id="B8" value="74"/>
            <count group_id="B9" value="1946"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>test sites on skin</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="343"/>
            <count group_id="B2" value="344"/>
            <count group_id="B3" value="347"/>
            <count group_id="B4" value="104"/>
            <count group_id="B5" value="242"/>
            <count group_id="B6" value="244"/>
            <count group_id="B7" value="248"/>
            <count group_id="B8" value="74"/>
            <count group_id="B9" value="1946"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="333"/>
                    <measurement group_id="B2" value="338"/>
                    <measurement group_id="B3" value="332"/>
                    <measurement group_id="B4" value="102"/>
                    <measurement group_id="B5" value="236"/>
                    <measurement group_id="B6" value="236"/>
                    <measurement group_id="B7" value="245"/>
                    <measurement group_id="B8" value="73"/>
                    <measurement group_id="B9" value="1895"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="105"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="56"/>
                    <measurement group_id="B6" value="64"/>
                    <measurement group_id="B7" value="67"/>
                    <measurement group_id="B8" value="23"/>
                    <measurement group_id="B9" value="538"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="251"/>
                    <measurement group_id="B2" value="245"/>
                    <measurement group_id="B3" value="242"/>
                    <measurement group_id="B4" value="72"/>
                    <measurement group_id="B5" value="186"/>
                    <measurement group_id="B6" value="180"/>
                    <measurement group_id="B7" value="181"/>
                    <measurement group_id="B8" value="51"/>
                    <measurement group_id="B9" value="1408"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic / Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="14"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiin or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="308"/>
                    <measurement group_id="B2" value="320"/>
                    <measurement group_id="B3" value="316"/>
                    <measurement group_id="B4" value="96"/>
                    <measurement group_id="B5" value="222"/>
                    <measurement group_id="B6" value="222"/>
                    <measurement group_id="B7" value="221"/>
                    <measurement group_id="B8" value="71"/>
                    <measurement group_id="B9" value="1776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="343"/>
                    <measurement group_id="B2" value="344"/>
                    <measurement group_id="B3" value="347"/>
                    <measurement group_id="B4" value="104"/>
                    <measurement group_id="B5" value="242"/>
                    <measurement group_id="B6" value="244"/>
                    <measurement group_id="B7" value="248"/>
                    <measurement group_id="B8" value="74"/>
                    <measurement group_id="B9" value="973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Responder Rate</title>
        <description>On the abdominal region a responder is a subject with a 2 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.&#xD;
On the inguinal region a responder is a subject with a 3 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.</description>
        <time_frame>baseline, 10 minutes post-product application and 6 hours post-product application</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3M CHG/IPA Prep C - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>3M CHG/IPA Prep CH - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>ChloraPrep - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O4">
            <title>Normal Saline - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O5">
            <title>3M CHG/IPA Prep C - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O6">
            <title>3M CHG/IPA Prep CH - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O7">
            <title>ChloraPrep - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O8">
            <title>Normal Saline - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Responder Rate</title>
          <description>On the abdominal region a responder is a subject with a 2 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.&#xD;
On the inguinal region a responder is a subject with a 3 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="202"/>
                <count group_id="O3" value="196"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="208"/>
                <count group_id="O6" value="209"/>
                <count group_id="O7" value="219"/>
                <count group_id="O8" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="165"/>
                    <measurement group_id="O3" value="163"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="81"/>
                    <measurement group_id="O6" value="98"/>
                    <measurement group_id="O7" value="116"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% confidence interval generation</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>81.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>75.6</ci_lower_limit>
            <ci_upper_limit>86.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% confidence interval generation</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>81.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>76.3</ci_lower_limit>
            <ci_upper_limit>87.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% confidence interval generation</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>83.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>77.9</ci_lower_limit>
            <ci_upper_limit>88.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% confidence interval generation</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>38.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>32.3</ci_lower_limit>
            <ci_upper_limit>45.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% confidence interval generation</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>46.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>40.1</ci_lower_limit>
            <ci_upper_limit>53.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% confidence interval generation</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>53.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>46.3</ci_lower_limit>
            <ci_upper_limit>59.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alternative Primary</title>
        <description>10 minute log reduction</description>
        <time_frame>Baseline and 10 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3M CHG/IPA Prep C - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O2">
            <title>3M CHG/IPA Prep CH - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O3">
            <title>ChloraPrep - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Alternative Primary</title>
          <description>10 minute log reduction</description>
          <units>log10/cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="208"/>
                <count group_id="O2" value="209"/>
                <count group_id="O3" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.84" spread="1.19"/>
                    <measurement group_id="O2" value="2.99" spread="1.12"/>
                    <measurement group_id="O3" value="3.17" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>A non-inferior margin of 0.5 log10/cm^2</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.57</ci_lower_limit>
            <ci_upper_limit>-0.10</ci_upper_limit>
            <estimate_desc>3M CHG/IPA C - Inguinal minus ChloraPrep - Inguinal</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Since there are two investigational products a Hochberg step-up procedure was used to adjust for multiplicity.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>A non-inferior margin of 0.5 log10/cm^2</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.44</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
            <estimate_desc>3M CHG/IPA CH - Inguinal minus ChloraPrep - Inguinal</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction of Skin Flora 6 Hours Post-treatment</title>
        <description>Log10/cm^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application</description>
        <time_frame>6 hours</time_frame>
        <population>The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).</population>
        <group_list>
          <group group_id="O1">
            <title>3M CHG/IPA Prep C - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>3M CHG/IPA Prep CH - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>ChloraPrep - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O4">
            <title>Normal Saline - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O5">
            <title>3M CHG/IPA Prep C - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O6">
            <title>3M CHG/IPA Prep CH - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O7">
            <title>ChloraPrep - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O8">
            <title>Normal Saline - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction of Skin Flora 6 Hours Post-treatment</title>
          <description>Log10/cm^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application</description>
          <population>The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).</population>
          <units>log10/cm^2 skin flora</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="202"/>
                <count group_id="O3" value="196"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="208"/>
                <count group_id="O6" value="209"/>
                <count group_id="O7" value="219"/>
                <count group_id="O8" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.83" spread="0.851"/>
                    <measurement group_id="O2" value="2.86" spread="0.899"/>
                    <measurement group_id="O3" value="2.83" spread="0.971"/>
                    <measurement group_id="O4" value="1.00" spread="0.971"/>
                    <measurement group_id="O5" value="3.46" spread="1.312"/>
                    <measurement group_id="O6" value="3.49" spread="1.329"/>
                    <measurement group_id="O7" value="3.69" spread="1.286"/>
                    <measurement group_id="O8" value="1.23" spread="0.732"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.83</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.85</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.86</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.90</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.83</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.97</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>1.00</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.97</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>3.46</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.31</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>3.49</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.33</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>3.69</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.29</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>1.23</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.73</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction of Skin Flora 10 Minutes Post-treatment</title>
        <description>Log10/cm^2 reduction of skin flora, relative to treatment day baseline (log10/cm^2) at 10 minutes post-treatment application</description>
        <time_frame>10 minutes</time_frame>
        <population>The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).</population>
        <group_list>
          <group group_id="O1">
            <title>3M CHG/IPA Prep C - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>3M CHG/IPA Prep CH - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>ChloraPrep - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O4">
            <title>Normal Saline - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O5">
            <title>3M CHG/IPA Prep C - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O6">
            <title>3M CHG/IPA Prep CH - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O7">
            <title>ChloraPrep - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O8">
            <title>Normal Saline - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction of Skin Flora 10 Minutes Post-treatment</title>
          <description>Log10/cm^2 reduction of skin flora, relative to treatment day baseline (log10/cm^2) at 10 minutes post-treatment application</description>
          <population>The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).</population>
          <units>log10/cm^2 skin flora</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="202"/>
                <count group_id="O3" value="196"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="208"/>
                <count group_id="O6" value="209"/>
                <count group_id="O7" value="219"/>
                <count group_id="O8" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.78" spread="0.935"/>
                    <measurement group_id="O2" value="2.73" spread="1.002"/>
                    <measurement group_id="O3" value="2.75" spread="0.973"/>
                    <measurement group_id="O4" value="0.76" spread="0.814"/>
                    <measurement group_id="O5" value="2.84" spread="1.191"/>
                    <measurement group_id="O6" value="2.99" spread="1.125"/>
                    <measurement group_id="O7" value="3.17" spread="1.243"/>
                    <measurement group_id="O8" value="1.01" spread="0.668"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.78</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.94</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.73</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.00</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.75</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.97</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>0.76</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.81</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.84</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.19</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.99</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.12</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>3.17</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.24</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>1.01</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.67</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Flora Recovery 6-hours Post-treatment</title>
        <description>Log10/cm^2 recovery of skin flora at 6 hours following application of treatment</description>
        <time_frame>6 hours post-treatment</time_frame>
        <population>The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).</population>
        <group_list>
          <group group_id="O1">
            <title>3M CHG/IPA Prep C - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>3M CHG/IPA Prep CH - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>ChloraPrep - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O4">
            <title>Normal Saline - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O5">
            <title>3M CHG/IPA Prep C - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O6">
            <title>3M CHG/IPA Prep CH - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O7">
            <title>ChloraPrep - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O8">
            <title>Normal Saline - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Flora Recovery 6-hours Post-treatment</title>
          <description>Log10/cm^2 recovery of skin flora at 6 hours following application of treatment</description>
          <population>The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).</population>
          <units>log10/cm^2 skin flora</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="201"/>
                <count group_id="O3" value="196"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="208"/>
                <count group_id="O6" value="209"/>
                <count group_id="O7" value="219"/>
                <count group_id="O8" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="0.840"/>
                    <measurement group_id="O2" value="0.74" spread="0.789"/>
                    <measurement group_id="O3" value="0.81" spread="0.935"/>
                    <measurement group_id="O4" value="2.65" spread="0.886"/>
                    <measurement group_id="O5" value="2.76" spread="1.202"/>
                    <measurement group_id="O6" value="2.73" spread="1.220"/>
                    <measurement group_id="O7" value="2.58" spread="1.182"/>
                    <measurement group_id="O8" value="4.85" spread="0.749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>0.80</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.84</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>0.74</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.79</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>0.81</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.94</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.65</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.89</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.76</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.20</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.73</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.22</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.58</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.18</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>4.85</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.75</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Flora Recovery 10 Minutes Post-treatment</title>
        <description>Log10/cm^2 recovery of skin flora at 10 minutes following application of study treatments.</description>
        <time_frame>10 minute post-product application</time_frame>
        <population>The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).</population>
        <group_list>
          <group group_id="O1">
            <title>3M CHG/IPA Prep C - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>3M CHG/IPA Prep CH - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>ChloraPrep - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O4">
            <title>Normal Saline - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O5">
            <title>3M CHG/IPA Prep C - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O6">
            <title>3M CHG/IPA Prep CH - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O7">
            <title>ChloraPrep - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O8">
            <title>Normal Saline - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Flora Recovery 10 Minutes Post-treatment</title>
          <description>Log10/cm^2 recovery of skin flora at 10 minutes following application of study treatments.</description>
          <population>The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).</population>
          <units>log10/cm^2 skin flora</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="201"/>
                <count group_id="O3" value="196"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="208"/>
                <count group_id="O6" value="208"/>
                <count group_id="O7" value="218"/>
                <count group_id="O8" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="0.947"/>
                    <measurement group_id="O2" value="0.88" spread="0.984"/>
                    <measurement group_id="O3" value="0.90" spread="0.938"/>
                    <measurement group_id="O4" value="2.88" spread="0.703"/>
                    <measurement group_id="O5" value="3.39" spread="1.096"/>
                    <measurement group_id="O6" value="3.21" spread="1.042"/>
                    <measurement group_id="O7" value="3.08" spread="1.137"/>
                    <measurement group_id="O8" value="5.08" spread="0.676"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>0.85</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.95</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>0.87</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.98</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>0.89</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.94</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>2.88</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.70</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>3.39</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.10</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>3.21</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.04</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>3.08</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.14</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>5.08</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.68</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Flora Baseline for the Abdomen and Inguinal Region.</title>
        <description>Log10/cm^2 baseline skin flora for abdominal and inguinal regions</description>
        <time_frame>Baseline</time_frame>
        <population>The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).</population>
        <group_list>
          <group group_id="O1">
            <title>3M CHG/IPA Prep C - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>3M CHG/IPA Prep CH - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>ChloraPrep - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O4">
            <title>Normal Saline - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O5">
            <title>3M CHG/IPA Prep C - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O6">
            <title>3M CHG/IPA Prep CH - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O7">
            <title>ChloraPrep - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O8">
            <title>Normal Saline - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Flora Baseline for the Abdomen and Inguinal Region.</title>
          <description>Log10/cm^2 baseline skin flora for abdominal and inguinal regions</description>
          <population>The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).</population>
          <units>log10/cm^2 skin flora</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="202"/>
                <count group_id="O3" value="196"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="208"/>
                <count group_id="O6" value="209"/>
                <count group_id="O7" value="219"/>
                <count group_id="O8" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.63" spread="0.460"/>
                    <measurement group_id="O2" value="3.61" spread="0.479"/>
                    <measurement group_id="O3" value="3.64" spread="0.487"/>
                    <measurement group_id="O4" value="3.64" spread="0.533"/>
                    <measurement group_id="O5" value="6.23" spread="0.604"/>
                    <measurement group_id="O6" value="6.21" spread="0.563"/>
                    <measurement group_id="O7" value="6.27" spread="0.618"/>
                    <measurement group_id="O8" value="6.09" spread="0.626"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>3.63</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.46</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>3.61</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.48</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>3.64</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.49</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>3.64</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.53</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>6.23</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.60</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>6.22</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.56</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>6.27</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.62</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Calculate mean value</non_inferiority_desc>
            <param_type>Mean value</param_type>
            <param_value>6.09</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.63</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score</title>
        <description>Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.</description>
        <time_frame>Baseline</time_frame>
        <population>The primary safety analysis data set used an Intent-To-Treat (ITT) population</population>
        <group_list>
          <group group_id="O1">
            <title>3M CHG/IPA Prep C - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.&#xD;
.</description>
          </group>
          <group group_id="O2">
            <title>3M CHG/IPA Prep CH - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>ChloraPrep - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O4">
            <title>Normal Saline - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O5">
            <title>3M CHG/IPA Prep C - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O6">
            <title>3M CHG/IPA Prep CH - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O7">
            <title>ChloraPrep - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O8">
            <title>Normal Saline - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score</title>
          <description>Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.</description>
          <population>The primary safety analysis data set used an Intent-To-Treat (ITT) population</population>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>test sites on skin</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="343"/>
                <count group_id="O2" value="344"/>
                <count group_id="O3" value="347"/>
                <count group_id="O4" value="104"/>
                <count group_id="O5" value="242"/>
                <count group_id="O6" value="244"/>
                <count group_id="O7" value="248"/>
                <count group_id="O8" value="74"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>test sites on skin</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="343"/>
                <count group_id="O2" value="344"/>
                <count group_id="O3" value="347"/>
                <count group_id="O4" value="104"/>
                <count group_id="O5" value="242"/>
                <count group_id="O6" value="244"/>
                <count group_id="O7" value="248"/>
                <count group_id="O8" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dryness-No Reaction (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343"/>
                    <measurement group_id="O2" value="344"/>
                    <measurement group_id="O3" value="347"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="240"/>
                    <measurement group_id="O6" value="244"/>
                    <measurement group_id="O7" value="248"/>
                    <measurement group_id="O8" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness-Mild (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-No Reaction (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343"/>
                    <measurement group_id="O2" value="344"/>
                    <measurement group_id="O3" value="347"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="240"/>
                    <measurement group_id="O6" value="244"/>
                    <measurement group_id="O7" value="248"/>
                    <measurement group_id="O8" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-Mild (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-No Reaction (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="340"/>
                    <measurement group_id="O2" value="343"/>
                    <measurement group_id="O3" value="347"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="239"/>
                    <measurement group_id="O6" value="243"/>
                    <measurement group_id="O7" value="247"/>
                    <measurement group_id="O8" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-Mild (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-No Reaction (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343"/>
                    <measurement group_id="O2" value="344"/>
                    <measurement group_id="O3" value="347"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="240"/>
                    <measurement group_id="O6" value="244"/>
                    <measurement group_id="O7" value="248"/>
                    <measurement group_id="O8" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-Mild (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score</title>
        <description>Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0=no reaction, 1=mild, 2=moderate, 3=severe</description>
        <time_frame>10 minutes post-treatment</time_frame>
        <population>The primary safety analysis data set used an Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>3M CHG/IPA Prep C - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>3M CHG/IPA Prep CH - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>ChloraPrep - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O4">
            <title>Normal Saline - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O5">
            <title>3M CHG/IPA Prep C - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O6">
            <title>3M CHG/IPA Prep CH - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O7">
            <title>ChloraPrep - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O8">
            <title>Normal Saline - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score</title>
          <description>Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0=no reaction, 1=mild, 2=moderate, 3=severe</description>
          <population>The primary safety analysis data set used an Intent to Treat population</population>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>test sites on skin</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="343"/>
                <count group_id="O2" value="344"/>
                <count group_id="O3" value="347"/>
                <count group_id="O4" value="104"/>
                <count group_id="O5" value="242"/>
                <count group_id="O6" value="244"/>
                <count group_id="O7" value="248"/>
                <count group_id="O8" value="74"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>test sites on skin</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="343"/>
                <count group_id="O2" value="344"/>
                <count group_id="O3" value="347"/>
                <count group_id="O4" value="104"/>
                <count group_id="O5" value="242"/>
                <count group_id="O6" value="244"/>
                <count group_id="O7" value="248"/>
                <count group_id="O8" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dryness-No Reaction (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343"/>
                    <measurement group_id="O2" value="344"/>
                    <measurement group_id="O3" value="347"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="242"/>
                    <measurement group_id="O6" value="244"/>
                    <measurement group_id="O7" value="248"/>
                    <measurement group_id="O8" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness-Mild (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-No Reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343"/>
                    <measurement group_id="O2" value="344"/>
                    <measurement group_id="O3" value="347"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="242"/>
                    <measurement group_id="O6" value="244"/>
                    <measurement group_id="O7" value="247"/>
                    <measurement group_id="O8" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-Mild (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-No Reaction (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="341"/>
                    <measurement group_id="O2" value="343"/>
                    <measurement group_id="O3" value="345"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="240"/>
                    <measurement group_id="O6" value="242"/>
                    <measurement group_id="O7" value="243"/>
                    <measurement group_id="O8" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-Mild (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-No Reaction (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343"/>
                    <measurement group_id="O2" value="344"/>
                    <measurement group_id="O3" value="347"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="242"/>
                    <measurement group_id="O6" value="244"/>
                    <measurement group_id="O7" value="248"/>
                    <measurement group_id="O8" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-Mild(1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety as Assessed by Skin Irritation Score</title>
        <description>Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.</description>
        <time_frame>6 hours post-treatment</time_frame>
        <population>The primary safety analysis dataset used an Intent-To-Treat (ITT) population</population>
        <group_list>
          <group group_id="O1">
            <title>3M CHG/IPA Prep C - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>3M CHG/IPA Prep CH - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O3">
            <title>ChloraPrep - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O4">
            <title>Normal Saline - Abdominal</title>
            <description>Applied topically to the abdominal region for 30 seconds.</description>
          </group>
          <group group_id="O5">
            <title>3M CHG/IPA Prep C - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O6">
            <title>3M CHG/IPA Prep CH - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O7">
            <title>ChloraPrep - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
          <group group_id="O8">
            <title>Normal Saline - Inguinal</title>
            <description>Applied topically to the inguinal region for 2 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety as Assessed by Skin Irritation Score</title>
          <description>Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.</description>
          <population>The primary safety analysis dataset used an Intent-To-Treat (ITT) population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="343"/>
                <count group_id="O2" value="344"/>
                <count group_id="O3" value="347"/>
                <count group_id="O4" value="104"/>
                <count group_id="O5" value="242"/>
                <count group_id="O6" value="244"/>
                <count group_id="O7" value="248"/>
                <count group_id="O8" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dryness-No Reaction (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="334"/>
                    <measurement group_id="O2" value="330"/>
                    <measurement group_id="O3" value="336"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="240"/>
                    <measurement group_id="O6" value="240"/>
                    <measurement group_id="O7" value="241"/>
                    <measurement group_id="O8" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness-Mild (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-No Reaction (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343"/>
                    <measurement group_id="O2" value="344"/>
                    <measurement group_id="O3" value="347"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="242"/>
                    <measurement group_id="O6" value="244"/>
                    <measurement group_id="O7" value="248"/>
                    <measurement group_id="O8" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-Mild (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-No Reaction (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="310"/>
                    <measurement group_id="O2" value="310"/>
                    <measurement group_id="O3" value="332"/>
                    <measurement group_id="O4" value="98"/>
                    <measurement group_id="O5" value="227"/>
                    <measurement group_id="O6" value="220"/>
                    <measurement group_id="O7" value="236"/>
                    <measurement group_id="O8" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-Mild (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="24"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-No Reaction (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="339"/>
                    <measurement group_id="O2" value="337"/>
                    <measurement group_id="O3" value="342"/>
                    <measurement group_id="O4" value="103"/>
                    <measurement group_id="O5" value="230"/>
                    <measurement group_id="O6" value="231"/>
                    <measurement group_id="O7" value="229"/>
                    <measurement group_id="O8" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-Mild (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="12"/>
                    <measurement group_id="O6" value="13"/>
                    <measurement group_id="O7" value="19"/>
                    <measurement group_id="O8" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-Moderate (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash-Severe (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>3M CHG/IPA Prep C - Abdominal</title>
          <description>Applied topically to the abdominal region for 30 seconds.</description>
        </group>
        <group group_id="E2">
          <title>3M CHG/IPA Prep CH - Abdominal</title>
          <description>Applied topically to the abdominal region for 30 seconds.</description>
        </group>
        <group group_id="E3">
          <title>ChloraPrep - Abdominal</title>
          <description>Applied topically to the abdominal region for 30 seconds.</description>
        </group>
        <group group_id="E4">
          <title>Normal Saline - Abdominal</title>
          <description>Applied topically to the abdominal region for 30 seconds.</description>
        </group>
        <group group_id="E5">
          <title>3M CHG/IPA Prep C - Inguinal</title>
          <description>Applied topically to the inguinal region for 2 minutes.</description>
        </group>
        <group group_id="E6">
          <title>3M CHG/IPA Prep CH - Inguinal</title>
          <description>Applied topically to the inguinal region for 2 minutes.</description>
        </group>
        <group group_id="E7">
          <title>ChloraPrep - Inguinal</title>
          <description>Applied topically to the inguinal region for 2 minutes.</description>
        </group>
        <group group_id="E8">
          <title>Normal Saline - Inguinal</title>
          <description>Applied topically to the inguinal region for 2 minutes.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="343"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="344"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="242"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="244"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="343"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="344"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="242"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="244"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="343"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="344"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="242"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="244"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Mild severity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="343"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="344"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="242"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="244"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Moderate severity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="343"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="344"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="242"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="244"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Not related to product</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="343"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="344"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="242"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="244"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Possibly related to products</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="343"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="344"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="242"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="244"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Probably related to product</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="343"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="344"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="242"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="244"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Anticipated</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="343"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="344"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="242"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="244"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Unexpected</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="343"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="344"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="242"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="244"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Joan Paulson</name_or_title>
      <organization>3M</organization>
      <phone>651-736-6583</phone>
      <email>jepaulson@mmm.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203591
org study id: EM-013260
nct id: NCT02203591
lead sponsor: 
The objective of this study is to demonstrate the antimicrobial efficacy of the 3M CHG/IPA
      Prep on skin flora of the abdominal and inguinal regions of human subjects.
The primary efficacy is evaluated by demonstration that the product provides a lower bound of
      the 95% confidence interval of percent responders that is greater than or equal to 70% On the
      abdominal site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at
      10 minutes and for whom the skin flora does not return to baseline at 6 hours.

      On the inguinal site, a responder is defined as a subject with a 3-log10/cm2 bacterial
      reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Responder Rate
time frame: baseline, 10 minutes post-product application and 6 hours post-product application
description: On the abdominal region a responder is a subject with a 2 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.
On the inguinal region a responder is a subject with a 3 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.
measure: Alternative Primary
time frame: Baseline and 10 minutes
description: 10 minute log reduction
measure: Reduction of Skin Flora 6 Hours Post-treatment
time frame: 6 hours
description: Log10/cm^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application
measure: Reduction of Skin Flora 10 Minutes Post-treatment
time frame: 10 minutes
description: Log10/cm^2 reduction of skin flora, relative to treatment day baseline (log10/cm^2) at 10 minutes post-treatment application
measure: Skin Flora Recovery 6-hours Post-treatment
time frame: 6 hours post-treatment
description: Log10/cm^2 recovery of skin flora at 6 hours following application of treatment
measure: Skin Flora Recovery 10 Minutes Post-treatment
time frame: 10 minute post-product application
description: Log10/cm^2 recovery of skin flora at 10 minutes following application of study treatments.
measure: Skin Flora Baseline for the Abdomen and Inguinal Region.
time frame: Baseline
description: Log10/cm^2 baseline skin flora for abdominal and inguinal regions
measure: Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
time frame: Baseline
description: Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.
measure: Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
time frame: 10 minutes post-treatment
description: Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0=no reaction, 1=mild, 2=moderate, 3=severe
measure: Safety as Assessed by Skin Irritation Score
time frame: 6 hours post-treatment
description: Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.
arm group label: 3M CHG/IPA Prep C
arm group type: Experimental
description: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
arm group label: 3M CHG/IPA Prep CH
arm group type: Experimental
description: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
arm group label: ChloraPrep
arm group type: Active Comparator
description: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
arm group label: Normal Saline
arm group type: Placebo Comparator
description: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
intervention type: Drug
intervention name: 3M CHG/IPA Prep C
description: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
arm group label: 3M CHG/IPA Prep C
other name: Chlorhexidine Gluconate and Isopropyl Alcohol
other name: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
other name: CHG 2%/IPA 70%
intervention type: Drug
intervention name: 3M CHG/IPA Prep CH
description: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
arm group label: 3M CHG/IPA Prep CH
other name: Chlorhexidine Gluconate and Isopropyl Alcohol
other name: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
other name: CHG 2%/IPA 70%
intervention type: Drug
intervention name: ChloraPrep
description: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
arm group label: ChloraPrep
other name: ChloraPrep Patient Preoperative Skin Preparation
other name: ChloraPrep One-Step
other name: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
other name: CHG2%/IPA 70%
other name: Chlorhexidine Gluconate and Isopropyl Alcohol
intervention type: Drug
intervention name: Normal Saline
description: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
arm group label: Normal Saline
other name: Sodium Chloride 0.9%
other name: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jamie Miller, ADN
role: Principal Investigator
affiliation: Independent Consultant
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ethanol
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 