<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/NCT03782103</url>
  </required_header>
  <id_info>
    <org_study_id>ZX-ZP-0092 / 865-107</org_study_id>
    <nct_id>NCT03782103</nct_id>
  </id_info>
  <brief_title>In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)</brief_title>
  <acronym>ZP</acronym>
  <official_title>Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zurex Pharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zurex Pharma, Inc.</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>
      The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex&#xD;
      Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of&#xD;
      human subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to measure the antimicrobial effectiveness of a single&#xD;
      investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical&#xD;
      Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™&#xD;
      as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle&#xD;
      as a negative control. For efficacy at 30 seconds post-prep, the test article should be&#xD;
      superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non-inferior to the&#xD;
      active control using a margin of 0.5 log10 CFU/cm2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">September 26, 2019</completion_date>
  <primary_completion_date type="Actual">May 12, 2019</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>Bacterial Reduction - Groin</measure>
    <time_frame>30 seconds post product application</time_frame>
    <description>A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bacterial Reduction - Abdomen</measure>
    <time_frame>30 seconds post product application</time_frame>
    <description>A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region</measure>
    <time_frame>6 hours post product applcation</time_frame>
    <description>Bacterial counts should not exceed baseline on the abdomen or groin region</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Surgical Skin Preparation</condition>
  <arm_group>
    <arm_group_label>ZuraPrep (70% IPA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Isopropyl alcohol (IPA) 70%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ChloraPrep</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZuraPrep Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Zurex Prep without IPA</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ZuraPrep Clear Solution</intervention_name>
    <description>Apply topically.</description>
    <arm_group_label>ZuraPrep (70% IPA)</arm_group_label>
    <other_name>Isopropyl alcohol 70%</other_name>
    <other_name>ZP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ChloraPrep</intervention_name>
    <description>Apply topically.</description>
    <arm_group_label>ChloraPrep</arm_group_label>
    <other_name>CHG 2%/IPA 70%</other_name>
    <other_name>Chlorhexidine gluconate 2% / Isopropyl alcohol 70%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ZuraPrep Vehicle</intervention_name>
    <description>Apply topically.</description>
    <arm_group_label>ZuraPrep Vehicle</arm_group_label>
    <other_name>Vehicle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects of any race&#xD;
&#xD;
          -  Subjects in good general health&#xD;
&#xD;
          -  Minimum bacterial baseline requirements on abdomen and groin&#xD;
&#xD;
          -  Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder&#xD;
             near or on the applicable test area.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Topical or systemic antimicrobial exposure within 14 days prior to screening and&#xD;
             treatment days, including antibiotics.&#xD;
&#xD;
          -  Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to&#xD;
             screening and treatment days, excluding contraception or post-menopausal treatment.&#xD;
&#xD;
          -  Subjects with allergies to study materials including isopropyl alcohol or&#xD;
             chlorhexidine gluconate.&#xD;
&#xD;
          -  Subjects with a history of skin sensitivity, skin allergies, or skin cancer.&#xD;
&#xD;
          -  Subjects who are pregnant, attempting pregnancy or nursing.&#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>M H Bashir, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Microbac Laboratories, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Microbac Laboratories, Inc.</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>June 2021</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>May 23, 2022</results_first_submitted>
  <results_first_submitted_qc>June 24, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 21, 2022</results_first_posted>
  <disposition_first_submitted>June 29, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>June 24, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 21, 2022</disposition_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</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>Ethanol</mesh_term>
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03782103/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Enrollment consists of subjects that advanced from screening to randomization and treatment. Each subject had 2 test products applied bilaterally; therefore, the numbers will not add up uniformly across arms due to the pre-determined cohort/block design. Result totals will be less than than the treated number as the per subject/area/intervention anatomical site must have an acceptable baseline count/flora.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Study Participants</title>
          <description>ZP (Isopropyl alcohol (IPA) 70%) or CP or ZP Vehicle, applied topically to abdominal (for 30 seconds) or groin (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="156"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>ZP</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>CP</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vehicle</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects must have the following bacteria counts to entry study, for the abdomen, the allowable baseline log10 CFU/cm2 value &gt; 3.0; for the groin, the allowable baseline log10 CFU/cm2 value &gt; 5.0.</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment Population</title>
          <description>Each subject could have received 2 out of 3 test products randomly assigned. Demographics were not stratified by test product due to study design. While 156 was the treated population, to be evaluable for efficacy, each subject anatomical sample site (4/per subject) would need to pass the minimum log10 CFU/cm2 baseline requirements.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="156"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Abdomen or groin</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="72"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.90" spread="14.93"/>
                  </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="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </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="41"/>
                  </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="0"/>
                  </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="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bacterial Reduction - Groin</title>
        <description>A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success.</description>
        <time_frame>30 seconds post product application</time_frame>
        <population>Treated subjects with a treatment day baseline criteria of 5.0-7.5 log10 CFU/cm^2 recoveries for each sampling site (2 groin sampling sites per subject).</population>
        <group_list>
          <group group_id="O1">
            <title>Mean Log Reduction - ZP (70% IPA) - Groin</title>
            <description>Isopropyl alcohol (IPA) 70%&#xD;
ZP: Apply topically.</description>
          </group>
          <group group_id="O2">
            <title>Mean Log Reduction - ChloraPrep - Groin</title>
            <description>Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%&#xD;
ChloraPrep: Apply topically.</description>
          </group>
          <group group_id="O3">
            <title>Mean Log Reduction - ZP Vehicle - Groin</title>
            <description>ZP without IPA&#xD;
ZP Vehicle: Apply topically.</description>
          </group>
        </group_list>
        <measure>
          <title>Bacterial Reduction - Groin</title>
          <description>A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success.</description>
          <population>Treated subjects with a treatment day baseline criteria of 5.0-7.5 log10 CFU/cm^2 recoveries for each sampling site (2 groin sampling sites per subject).</population>
          <units>log 10 CFU/cm2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Abdomen or groin</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
                <count group_id="O2" value="156"/>
                <count group_id="O3" value="156"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Abdomen or groin</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.133" spread="0.4"/>
                    <measurement group_id="O2" value="3.642" spread="0.5"/>
                    <measurement group_id="O3" value="1.277" spread="0.6"/>
                  </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>Groin 30 seconds post product application, Average Treatment Effect, 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 CFU/cm^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm^2 bacterial counts as a covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Investigational product upper bounds must be less than 0.5.</non_inferiority_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.2845</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6033</ci_lower_limit>
            <ci_upper_limit>0.0334</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Groin 30 seconds post product application, Average Treatment Effect, 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 CFU/cm^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm^2 bacterial counts as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Investigational product lower bounds must be greater than 1.2.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.8535</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.5415</ci_lower_limit>
            <ci_upper_limit>3.1655</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bacterial Reduction - Abdomen</title>
        <description>A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success.</description>
        <time_frame>30 seconds post product application</time_frame>
        <population>Treated subjects with a treatment day baseline criteria of 3.0 - 5.5 Log10 CFU/cm^2 recoveries.</population>
        <group_list>
          <group group_id="O1">
            <title>Mean Log Reduction - ZP (70% IPA) - Abdomen</title>
            <description>Isopropyl alcohol (IPA) 70%&#xD;
ZP: Apply topically.</description>
          </group>
          <group group_id="O2">
            <title>Mean Log Reduction - ChloraPrep - Abdomen</title>
            <description>Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%&#xD;
ChloraPrep: Apply topically.</description>
          </group>
          <group group_id="O3">
            <title>Mean Log Reduction - ZP Vehicle - Abdomen</title>
            <description>ZP without IPA&#xD;
ZP Vehicle: Apply topically.</description>
          </group>
        </group_list>
        <measure>
          <title>Bacterial Reduction - Abdomen</title>
          <description>A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success.</description>
          <population>Treated subjects with a treatment day baseline criteria of 3.0 - 5.5 Log10 CFU/cm^2 recoveries.</population>
          <units>Log10 CFU/cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Abdomen or groin</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
                <count group_id="O2" value="156"/>
                <count group_id="O3" value="156"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Abdomen or groin</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.036" spread="0.4"/>
                    <measurement group_id="O2" value="3.087" spread="0.4"/>
                    <measurement group_id="O3" value="1.234" spread="0.5"/>
                  </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>Abdomen 30 seconds post product application, Average Treatment Effect, 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 CFU/cm^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm^2 bacterial counts as a covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Investigational product average treatment effect upper bounds cannot be more than 0.5.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0577</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1457</ci_lower_limit>
            <ci_upper_limit>0.2611</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Abdomen 30 seconds post product application, Average Treatment Effect, 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 CFU/cm^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm^2 bacterial counts as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Investigational product lower bounds must be greater than 1.2.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.8208</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.6153</ci_lower_limit>
            <ci_upper_limit>2.0264</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region</title>
        <description>Bacterial counts should not exceed baseline on the abdomen or groin region</description>
        <time_frame>6 hours post product applcation</time_frame>
        <population>Subjects were treated and post treatment the 6 hour log10 CFU/cm2 values were evaluated for persistence. If the 6 hour value was below the baseline log10CFU/cm2 value, then the site had a persistent effect. This was calculated as a binary variable: 1 if the site had a persistent effect; 0 if not.</population>
        <group_list>
          <group group_id="O1">
            <title>ZP (70% IPA)</title>
            <description>Isopropyl alcohol (IPA) 70% - 6 hr post product application&#xD;
ZP: Apply topically.</description>
          </group>
        </group_list>
        <measure>
          <title>Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region</title>
          <description>Bacterial counts should not exceed baseline on the abdomen or groin region</description>
          <population>Subjects were treated and post treatment the 6 hour log10 CFU/cm2 values were evaluated for persistence. If the 6 hour value was below the baseline log10CFU/cm2 value, then the site had a persistent effect. This was calculated as a binary variable: 1 if the site had a persistent effect; 0 if not.</population>
          <units>Abd or groin with persistent effect</units>
          <param>Number</param>
          <units_analyzed>Abdomen or groin</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Abdomen or groin</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 hours post product application</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Zurex Prep (70% IPA)</title>
          <description>Isopropyl alcohol (IPA) 70%&#xD;
ZuraGard Clear Solution: Apply topically.</description>
        </group>
        <group group_id="E2">
          <title>ChloraPrep</title>
          <description>Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%&#xD;
ChloraPrep: Apply topically.</description>
        </group>
        <group group_id="E3">
          <title>Zurex Prep Vehicle</title>
          <description>Zurex Prep without IPA&#xD;
Zurex Prep Vehicle: Apply topically.</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="156"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
              </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="156"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
              </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>Andrew Morgan Exec. VP RA/QA Clinical</name_or_title>
      <organization>Zurex Pharma</organization>
      <phone>16082175239</phone>
      <email>amorgan1@charter.net</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/NCT03782103
org study id: ZX-ZP-0092 / 865-107
nct id: NCT03782103
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex
      Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of
      human subjects.
The primary objective of this study is to measure the antimicrobial effectiveness of a single
      investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical
      Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™
      as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle
      as a negative control. For efficacy at 30 seconds post-prep, the test article should be
      superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non-inferior to the
      active control using a margin of 0.5 log10 CFU/cm2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Bacterial Reduction - Groin
time frame: 30 seconds post product application
description: A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success.
measure: Bacterial Reduction - Abdomen
time frame: 30 seconds post product application
description: A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success.
measure: Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region
time frame: 6 hours post product applcation
description: Bacterial counts should not exceed baseline on the abdomen or groin region
arm group label: ZuraPrep (70% IPA)
arm group type: Experimental
description: Isopropyl alcohol (IPA) 70%
arm group label: ChloraPrep
arm group type: Active Comparator
description: Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
arm group label: ZuraPrep Vehicle
arm group type: Placebo Comparator
description: Zurex Prep without IPA
intervention type: Drug
intervention name: ZuraPrep Clear Solution
description: Apply topically.
arm group label: ZuraPrep (70% IPA)
other name: Isopropyl alcohol 70%
other name: ZP
intervention type: Drug
intervention name: ChloraPrep
description: Apply topically.
arm group label: ChloraPrep
other name: CHG 2%/IPA 70%
other name: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
intervention type: Drug
intervention name: ZuraPrep Vehicle
description: Apply topically.
arm group label: ZuraPrep Vehicle
other name: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: M H Bashir, MD
role: Principal Investigator
affiliation: Microbac Laboratories, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ethanol
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 