<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/NCT02222896</url>
  </required_header>
  <id_info>
    <org_study_id>R13-053</org_study_id>
    <nct_id>NCT02222896</nct_id>
  </id_info>
  <brief_title>Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects</brief_title>
  <official_title>Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medline Industries</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medline Industries</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on&#xD;
      the skin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin&#xD;
      areas post CHG application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin</measure>
    <time_frame>10 minutes, 6 hours, 8 hours</time_frame>
    <description>Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline.&#xD;
Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">347</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Chlorhexidine Gluconate Cloth</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2% CHG, single application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Cloth</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Excipients on cloth</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Chlorhexidine gluconate solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dynahex 2% CHG</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine Gluconate</intervention_name>
    <description>2% CHG solution on cloth</description>
    <arm_group_label>Chlorhexidine Gluconate Cloth</arm_group_label>
    <other_name>CHG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Excipients of CHG product only</description>
    <arm_group_label>Vehicle Cloth</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DynaHex-2</intervention_name>
    <description>2% CHG solution</description>
    <arm_group_label>Active Chlorhexidine gluconate solution</arm_group_label>
    <other_name>CHG 2%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or Females&#xD;
&#xD;
          -  16 years of age or older&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Good Health&#xD;
&#xD;
          -  Six inches of abdomen and groin areas without tattoos, or skin disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dermatological Conditions&#xD;
&#xD;
          -  Sensitivity to latex&#xD;
&#xD;
          -  Sensitivity to CHG&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>H Bashir</last_name>
    <role>Principal Investigator</role>
    <affiliation>MBT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MBT</name>
      <address>
        <city>Sterling</city>
        <state>Virginia</state>
        <zip>20164</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 10, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>February 3, 2016</results_first_submitted>
  <results_first_submitted_qc>April 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 21, 2021</results_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Preoperative surgical skin preparation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data to be shared with FDA</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Upon achieving sufficient microbial growth prior to product application on either the abdomen, groin or both abdomen and groin regions, sites of the participant were then randomized to receive one or two products for evaluation for up 4 sites. Differences in the number of participants is based on microbial qualification.</recruitment_details>
      <pre_assignment_details>The sites of the participant were tested for microbial activity after product application. In some instances, more than one product could have been applied to a participant but only one product per site (groin and/or abdomen sites). Up to 4 sites could be treated: 1)both groin and abdomen, 2) only the groin or 3) only the abdomen.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CHG Cloth</title>
          <description>CHG 3 min application</description>
        </group>
        <group group_id="P2">
          <title>Vehicle</title>
          <description>Vehicle, 3 min application</description>
        </group>
        <group group_id="P3">
          <title>Comparator CHG</title>
          <description>CHG Comparator, 3 min application</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Abdomen</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="253"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="253"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="219"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="221"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="32"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not qualify</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="32"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Groin</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="254"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="250"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="211"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="210"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="40"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not qualify</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="40"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CHG, Vehicle, Comparator CHG</title>
          <description>Single applications of products. 3 min application for CHG and Vehicle. Comparator CHG applied according to instructions.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="347"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="317"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35" lower_limit="16" upper_limit="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin</title>
        <description>Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline.&#xD;
Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels.</description>
        <time_frame>10 minutes, 6 hours, 8 hours</time_frame>
        <population>Participants received product on up to 2 abdomen and 2 groin sites, 2 abdomen only sites or 2 groin sites only.</population>
        <group_list>
          <group group_id="O1">
            <title>CHG Cloth Abdomen</title>
            <description>CHG 3 min application to abdomen</description>
          </group>
          <group group_id="O2">
            <title>CHG Cloth Groin</title>
            <description>CHG 3 min application to groin</description>
          </group>
          <group group_id="O3">
            <title>Vehicle Abdomen</title>
            <description>Vehicle 3 min application to abdomen</description>
          </group>
          <group group_id="O4">
            <title>Vehicle Groin</title>
            <description>Vehicle 3 min application to groin</description>
          </group>
          <group group_id="O5">
            <title>Comparator CHG Abdomen</title>
            <description>CHG comparator applied to abdomen</description>
          </group>
          <group group_id="O6">
            <title>Comparator CHG Groin</title>
            <description>CHG comparator applied to groin</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin</title>
          <description>Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline.&#xD;
Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels.</description>
          <population>Participants received product on up to 2 abdomen and 2 groin sites, 2 abdomen only sites or 2 groin sites only.</population>
          <units>Percent of Sites</units>
          <param>Number</param>
          <units_analyzed>Sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="254"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="48"/>
                <count group_id="O5" value="253"/>
                <count group_id="O6" value="250"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="254"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="48"/>
                <count group_id="O5" value="253"/>
                <count group_id="O6" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>10 min</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="86"/>
                    <measurement group_id="O3" value="50"/>
                    <measurement group_id="O4" value="25"/>
                    <measurement group_id="O5" value="85"/>
                    <measurement group_id="O6" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="98"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                    <measurement group_id="O6" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="98"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                    <measurement group_id="O6" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The total number of participants that received each product. Some participants could have received up to 2 products at the same time.</desc>
      <group_list>
        <group group_id="E1">
          <title>CHG Cloth</title>
          <description>Single application</description>
        </group>
        <group group_id="E2">
          <title>Vehicle</title>
          <description>Single application</description>
        </group>
        <group group_id="E3">
          <title>Comparative CHG</title>
          <description>Single application</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="297"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
              </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>Confidential information based on contract.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Bashir</name_or_title>
      <organization>Microbac</organization>
      <phone>703-925-9366</phone>
      <email>muhammad.bashir@microbac.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/NCT02222896
org study id: R13-053
nct id: NCT02222896
lead sponsor: 
has dmc: No
Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on
      the skin.
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin
      areas post CHG application.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin
time frame: 10 minutes, 6 hours, 8 hours
description: Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline.
Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels.
arm group label: Chlorhexidine Gluconate Cloth
arm group type: Experimental
description: 2% CHG, single application
arm group label: Vehicle Cloth
arm group type: Placebo Comparator
description: Excipients on cloth
arm group label: Active Chlorhexidine gluconate solution
arm group type: Active Comparator
description: Dynahex 2% CHG
intervention type: Drug
intervention name: Chlorhexidine Gluconate
description: 2% CHG solution on cloth
arm group label: Chlorhexidine Gluconate Cloth
other name: CHG
intervention type: Other
intervention name: Vehicle
description: Excipients of CHG product only
arm group label: Vehicle Cloth
other name: Control
intervention type: Drug
intervention name: DynaHex-2
description: 2% CHG solution
arm group label: Active Chlorhexidine gluconate solution
other name: CHG 2%
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: H Bashir
role: Principal Investigator
affiliation: MBT
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
sharing ipd: Yes
ipd description: Data to be shared with FDA
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 