<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/NCT03229759</url>
  </required_header>
  <id_info>
    <org_study_id>MPS-17IPVAW10</org_study_id>
    <nct_id>NCT03229759</nct_id>
  </id_info>
  <brief_title>Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth</brief_title>
  <official_title>A Randomized Single Center Blinded Clinical Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth Compared to Vehicle and 0.9% Saline</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Becton, Dickinson and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Becton, Dickinson and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthy volunteers will receive treatment to two body locations with the investigational&#xD;
      product and placebo and the antimicrobial effectiveness of each treatment will be measured.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 21, 2017</start_date>
  <completion_date type="Actual">August 4, 2017</completion_date>
  <primary_completion_date type="Actual">August 4, 2017</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial Count at 10 Minutes Post Application</measure>
    <time_frame>10 minutes after application of test product</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Preoperative Skin Preparation</condition>
  <arm_group>
    <arm_group_label>Investigational Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Polyester cloth impregnated with investigational product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Control (VC)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Polyester cloth impregnated with the vehicle control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline Control (SC)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline applied wtih polyester cloth</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Octenidine Dihydrocloride in aqueous solution</intervention_name>
    <description>application of investigational product</description>
    <arm_group_label>Investigational Product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vehicle Control</intervention_name>
    <description>application of vehicle control</description>
    <arm_group_label>Vehicle Control (VC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline Control</intervention_name>
    <description>application of placebo</description>
    <arm_group_label>Saline Control (SC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and/or females, at least 18 years or older and of any race.&#xD;
&#xD;
          -  Are in good general health.&#xD;
&#xD;
          -  Unable to become pregnant, or willing to use an acceptable method of contraception&#xD;
             (i.e. oral contraception, intra-uterine device [IUD], diaphragm, condom, abstinence,&#xD;
             bilateral Tubal ligation, or are in a monogamous relationship with a partner who has&#xD;
             had a Vasectomy) to prevent pregnancy for at least 14 days immediately preceding&#xD;
             Treatment Day and throughout the duration of the study, if female of child-bearing&#xD;
             potential.&#xD;
&#xD;
          -  All female subjects must have a negative urine pregnancy test on Treatment Day prior&#xD;
             to any applications of the study products.&#xD;
&#xD;
          -  Have skin within 6 inches of the test sites that is free of dermatoses, abrasions,&#xD;
             cuts, lesions or other skin disorders.&#xD;
&#xD;
          -  Cooperative and willing to follow Subject Instructions&#xD;
&#xD;
          -  Cooperative and willing to sign Consent Form and HIPAA Authorization Form.&#xD;
&#xD;
          -  Able to read, write and follow instructions in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exposure to topical or systemic antimicrobials or any other product known to affect&#xD;
             the normal microbial flora of the skin, antibiotics or steroids (other than hormones&#xD;
             for contraception or post-menopausal reasons) exposure within 14 days prior to&#xD;
             Treatment Day and for the remainder of the study. Restrictions include, but are not&#xD;
             limited to antimicrobial-containing soaps, antiperspirants/deodorants, shampoos,&#xD;
             lotions, perfumes, after shaves, and colognes.&#xD;
&#xD;
          -  Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools&#xD;
             within 14 days prior to Treatment Day and for the remainder of the study.&#xD;
&#xD;
          -  Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable&#xD;
             test areas) within 14 days prior to Treatment Day and for the remainder of the study.&#xD;
&#xD;
          -  Contact with strong detergents, solvents, acids, bases, bug repellant, fabric&#xD;
             softener-treated clothing, UV treated clothing or other household chemicals in the&#xD;
             applicable test areas within 14 days of the Treatment Day and for the remainder of the&#xD;
             study.&#xD;
&#xD;
          -  Subjects who have a history of sensitivity to vinyl, natural rubber latex, adhesive&#xD;
             skin products (e.g., Band-Aids, medical tapes), polyester, metals, inks, common&#xD;
             antibacterial agents found in common personal beauty or personal care soaps, lotions,&#xD;
             or ointments&#xD;
&#xD;
          -  Subjects who have asthma requiring medication, diabetes, hepatitis B or C, an organ&#xD;
             transplant, mitral valve prolapse with a heart murmur, congenital heart disease,&#xD;
             lupus, Crohn's disease, medicated multiple sclerosis, internal prosthesis or any&#xD;
             immunocompromised conditions (such as AIDS or HIV positive).&#xD;
&#xD;
          -  Subjects who have a history of skin allergies.&#xD;
&#xD;
          -  Subjects who have a history of skin cancer within 6 inches of the applicable test&#xD;
             areas or have received treatment for any type of internal cancer within the 5 years&#xD;
             prior to enrollment.&#xD;
&#xD;
          -  Any tattoos or scars on the test sites or within 2 inches of the test sites; skin&#xD;
             blemishes or warts may be permissible with the specific approval of the Principal&#xD;
             Investigator or consulting physician.&#xD;
&#xD;
          -  Dermatoses, cuts, lesions, active skin rashes, scabs, breaks in the skin or other skin&#xD;
             disorders within 6 inches on or around the test sites.&#xD;
&#xD;
          -  A currently active skin disease or inflammatory skin condition (for example contact&#xD;
             dermatitis; psoriasis, and eczema) anywhere on the body.&#xD;
&#xD;
          -  Subjects who are pregnant, attempting pregnancy, or nursing.&#xD;
&#xD;
          -  Subjects who have showered or bathed within at least 72 hours of the Treatment Day&#xD;
             (sponge baths may be taken, however, the lower abdomen and upper thigh region must be&#xD;
             avoided).&#xD;
&#xD;
          -  Subjects who receive an irritation score of 1 (any redness, swelling, rash, or dryness&#xD;
             present at any treatment area) for any individual skin condition prior to the&#xD;
             Treatment Day baseline sample collection.&#xD;
&#xD;
          -  Participation in another clinical trial in the 30 days prior to signing the informed&#xD;
             consent for this study, current enrollment in another clinical trial, or have already&#xD;
             participated in this study.&#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>Christopher Beausoleil</last_name>
    <role>Principal Investigator</role>
    <affiliation>BioScience Laboratories</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BioScience Laboratories</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>March 2021</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <results_first_submitted>October 28, 2020</results_first_submitted>
  <results_first_submitted_qc>March 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 23, 2021</results_first_posted>
  <disposition_first_submitted>March 5, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>March 26, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 23, 2021</disposition_first_posted>
  <last_update_submitted>March 26, 2021</last_update_submitted>
  <last_update_submitted_qc>March 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Octenidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 25, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03229759/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03229759/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were only treated if baseline bacterial counts met the inclusion criteria.&#xD;
Participants were treated with 2 of 3 study products (Investigational Product, saline control, vehicle control) 1 on the left side of the body (both groin and abdomen), 1 on the right side of the body (both groin and abdomen). Therefore, treatment groups are not discrete categories.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Participants</title>
          <description>All screened participants</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Treated</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated With Investigational Product</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated With Vehicle Control</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated With Saline Control</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screen Failure</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants were treated with multiple study products. Therefore, treatment groups are not discrete categories and cannot be displayed by treatment group.</population>
      <group_list>
        <group group_id="B1">
          <title>Participants Treated</title>
          <description>Participants who received study product at at least 1 treatment site (abdomen and/or groin). Participants were treated with 2 of 3 study products, investigational product (IP), saline control (SC), and/or vehicle control (VC). Therefore, treatments arms are not discrete groups of participants. Therefore, baseline data are presented for all treated participants and not by treatment arm.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="69"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41" spread="17"/>
                  </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="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </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="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bacterial Count at 10 Minutes Post Application</title>
        <time_frame>10 minutes after application of test product</time_frame>
        <population>Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 10 minutes.</population>
        <group_list>
          <group group_id="O1">
            <title>Investigational Product</title>
            <description>Investigational Product (IP) - Thermally treated polyester cloths impregnated with 0.4% weight by volume octenidine dihydrochloride (OCT) aqueous solution</description>
          </group>
          <group group_id="O2">
            <title>Saline Control</title>
            <description>Saline Control (SC) - 0.9% saline applied with polyester cloths</description>
          </group>
          <group group_id="O3">
            <title>Vehicle Control</title>
            <description>Vehicle Control (VC) Thermally treated polyester cloths impregnated with vehicle formulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Bacterial Count at 10 Minutes Post Application</title>
          <population>Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 10 minutes.</population>
          <units>log10 CFU/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="41"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abdomen- Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.55" spread="0.40"/>
                    <measurement group_id="O2" value="3.61" spread="0.41"/>
                    <measurement group_id="O3" value="3.66" spread="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen- 10 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.19" spread="1.28"/>
                    <measurement group_id="O2" value="2.64" spread="0.58"/>
                    <measurement group_id="O3" value="2.56" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Groin- Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.95" spread="0.60"/>
                    <measurement group_id="O2" value="6.07" spread="0.53"/>
                    <measurement group_id="O3" value="5.89" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Groin- 10 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.98" spread="1.14"/>
                    <measurement group_id="O2" value="4.90" spread="0.56"/>
                    <measurement group_id="O3" value="4.25" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Test on abdomen Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>2.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Tested on the abdomen Analysis was performed based on deferral letters from the FDA. Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Groin</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.38</ci_lower_limit>
            <ci_upper_limit>2.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Groin</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.79</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 minutes</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Subject Treated</title>
          <description>Participants who received study product at at least 1 treatment site (abdomen and/or groin). Participants were treated with 2 of 3 study products, investigational product (IP), saline control (SC), and/or vehicle control (VC). Therefore, treatments arms are not discrete groups of participants. Therefore, adverse event data are presented for all treated participants and not by treatment arm.</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="69"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="69"/>
              </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 NOT 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>Erin Zook</name_or_title>
      <organization>Becton Dickinson</organization>
      <phone>224-358-5019</phone>
      <email>erin.zook@bd.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/NCT03229759
org study id: MPS-17IPVAW10
nct id: NCT03229759
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Healthy volunteers will receive treatment to two body locations with the investigational
      product and placebo and the antimicrobial effectiveness of each treatment will be measured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Bacterial Count at 10 Minutes Post Application
time frame: 10 minutes after application of test product
arm group label: Investigational Product
arm group type: Experimental
description: Polyester cloth impregnated with investigational product
arm group label: Vehicle Control (VC)
arm group type: Placebo Comparator
description: Polyester cloth impregnated with the vehicle control
arm group label: Saline Control (SC)
arm group type: Placebo Comparator
description: Saline applied wtih polyester cloth
intervention type: Drug
intervention name: Octenidine Dihydrocloride in aqueous solution
description: application of investigational product
arm group label: Investigational Product
intervention type: Other
intervention name: Vehicle Control
description: application of vehicle control
arm group label: Vehicle Control (VC)
intervention type: Other
intervention name: Saline Control
description: application of placebo
arm group label: Saline Control (SC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christopher Beausoleil
role: Principal Investigator
affiliation: BioScience Laboratories
facility: 
country: United States
responsible party type: Sponsor
mesh term: Octenidine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 