<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/NCT03817580</url>
  </required_header>
  <id_info>
    <org_study_id>ER18/282</org_study_id>
    <nct_id>NCT03817580</nct_id>
  </id_info>
  <brief_title>Comparative Study of Antimicrobial Effectiveness</brief_title>
  <official_title>Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml Project X, 5.1 ml Project X and Prevantics® Maxi Swabstick Following ASTM E1173</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Professional Disposables International, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Professional Disposables International, 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>
      Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml Project X, 5.1ml Project&#xD;
      X and Prevantics® Maxi Swabstick following ASTM E1173 - Standard Test Method for Evaluation&#xD;
      of Preoperative, Precatheterization, or Preinjection Skin Preparations, ASTM International,&#xD;
      West Conshohocken, PA, 2015,&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">June 4, 2019</completion_date>
  <primary_completion_date type="Actual">June 4, 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 (Participant)</masking>
    <masking_description>Samples are blinded to the participant and technical team.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Bacterial Microflora on the Inguinal Area</measure>
    <time_frame>30 seconds</time_frame>
    <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Bacterial Microflora on the Inguinal Area</measure>
    <time_frame>10 minutes</time_frame>
    <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Bacterial Microflora on the Inguinal Area</measure>
    <time_frame>6 hours</time_frame>
    <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Bacterial Microflora on the Abdomen</measure>
    <time_frame>30 seconds</time_frame>
    <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Bacterial Microflora on the Abdomen</measure>
    <time_frame>10 minutes</time_frame>
    <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Bacterial Microflora on the Abdomen</measure>
    <time_frame>6 hours</time_frame>
    <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Bacterial Microflora Reduction</condition>
  <arm_group>
    <arm_group_label>Project X 26ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Project X 5.1ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prevantics Maxi Swabstick</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Project X 26ml</intervention_name>
    <description>Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
    <arm_group_label>Project X 26ml</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Project X 5.1ml</intervention_name>
    <description>Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
    <arm_group_label>Project X 5.1ml</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prevantics Maxi Swabstick</intervention_name>
    <description>Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
    <arm_group_label>Prevantics Maxi Swabstick</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female at least 18 years of age and of any race&#xD;
&#xD;
          2. In good general health&#xD;
&#xD;
          3. Read, understand and sign the Informed Consent Form (ICF)&#xD;
&#xD;
          4. If female of child-bearing potential, are willing to use an acceptable method of&#xD;
             contraception to prevent pregnancy (i.e. oral contraceptive, intra-uterine device,&#xD;
             diaphragm, condom, abstinence, bilateral tubal ligation, or are in a monogamous&#xD;
             relationship with a partner who has had a vasectomy)&#xD;
&#xD;
          5. Female subjects of child-bearing potential, must have a negative Urine Pregnancy Test&#xD;
             (UPT) on Treatment Day prior to any applications of the study products&#xD;
&#xD;
          6. Screening Day Baseline microbial counts are at least 3.11 colony forming units&#xD;
             (CFU)/cm2 bilaterally from the skin of the abdomen, and 5.00 log10 colony forming&#xD;
             units (CFU)/cm2 bilaterally from the skin of the groin (not applicable for&#xD;
             Neutralization study)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos,&#xD;
             or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds,&#xD;
             or sunbathing during the 14-day washout conditioning period and during the test period&#xD;
             (7-day for Neutralization study)&#xD;
&#xD;
          2. Exposure of the test sites to strong detergents, solvents, or other irritants during&#xD;
             the 14-day washout conditioning period and during the test period (7-day for&#xD;
             Neutralization study)&#xD;
&#xD;
          3. Wear fabric softener, bug repellent or UV-treated clothing during the 14-day washout&#xD;
             conditioning period and during the test period (7-day for Neutralization study)&#xD;
&#xD;
          4. Receive an irritation score of 1 (any redness, swelling, rash, or dryness present at&#xD;
             any treatment area) for any individual skin condition prior to the Screening Day&#xD;
             baseline or Treatment Day baseline sample collection or Neutralization study&#xD;
&#xD;
          5. Use of systemic or topical antibiotic medications, steroid medications (other than for&#xD;
             hormonal contraception or post-menopausal reasons), or any other product known to&#xD;
             affect the normal microbial flora of the skin during the 14-day washout conditioning&#xD;
             period and during the test period (7-day for Neutralization study)&#xD;
&#xD;
          6. Known allergies or sensitivities to vinyl, latex (rubber), alcohols, metals, inks, or&#xD;
             tape adhesives, or to common antibacterial agents found in soaps, lotions, or&#xD;
             ointments, particularly isopropyl alcohol or chlorhexidine gluconate&#xD;
&#xD;
          7. A medical diagnosis of a physical condition, such as a current or recent severe&#xD;
             illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapses,&#xD;
             congenital heart disease, internal prostheses, or any immunocompromised conditions&#xD;
             such as AIDS (or HIV positive)&#xD;
&#xD;
          8. Pregnancy, plans to become pregnant within the washout and test periods of the study,&#xD;
             or nursing a child&#xD;
&#xD;
          9. Any tattoos or scars within 2&quot; (5.08 cm) of the test sites&#xD;
&#xD;
         10. Dermatoses, cuts, lesions, active skin rashes, or breaks or other skin disorders&#xD;
             within 6&quot; on or around the test sites&#xD;
&#xD;
         11. A currently active skin disease or inflammatory skin condition (for example, contact&#xD;
             dermatitis) anywhere on the body that, in the opinion of the Consulting Physician or&#xD;
             PI, would compromise subject safety or study integrity&#xD;
&#xD;
         12. Showering, bathing, or swimming within the 72-hour period prior to sampling for&#xD;
             baseline screening, Treatment Day, and throughout the test period (not applicable for&#xD;
             Neutralization study)&#xD;
&#xD;
         13. Participation in another clinical study in the past 30 days or current participation&#xD;
             in another clinical study at time of signing informed consent&#xD;
&#xD;
         14. Any medical condition or use of any medications that, in the opinion of the PI, should&#xD;
             preclude participation&#xD;
&#xD;
         15. Unwillingness to fulfill the performance requirements of the 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>Rozalia Olsavszky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eurofins EVIC</name>
      <address>
        <city>Bucharest</city>
        <zip>040256</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <results_first_submitted>June 17, 2021</results_first_submitted>
  <results_first_submitted_qc>October 4, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 22, 2021</results_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>January 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03817580/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>170 individual subjects were consented, screened, treated and completed the study. Each subject is able to receive 2 test products (1 on each side of their body).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Project X 26ml</title>
          <description>3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 26ml volume. Single use.&#xD;
Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
        </group>
        <group group_id="P2">
          <title>Project X 5.1ml</title>
          <description>3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 5.1ml volume. Single use.&#xD;
Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
        </group>
        <group group_id="P3">
          <title>Prevantics Maxi Swabstick</title>
          <description>3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use.&#xD;
Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="56"/>
                <participants group_id="P3" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="56"/>
                <participants group_id="P3" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Project X 26ml</title>
          <description>3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 26ml volume. Single use.&#xD;
Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
        </group>
        <group group_id="B2">
          <title>Project X 5.1ml</title>
          <description>3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 5.1ml volume. Single use.&#xD;
Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
        </group>
        <group group_id="B3">
          <title>Prevantics Maxi Swabstick</title>
          <description>3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use.&#xD;
Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="57"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="57"/>
            <count group_id="B4" value="170"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="58.4" lower_limit="30" upper_limit="70"/>
                    <measurement group_id="B2" value="56.8" lower_limit="30" upper_limit="70"/>
                    <measurement group_id="B3" value="57.6" lower_limit="30" upper_limit="70"/>
                    <measurement group_id="B4" value="57.6" lower_limit="30" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="33"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="170"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Bacterial Microflora on the Inguinal Area</title>
        <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
        <time_frame>30 seconds</time_frame>
        <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
        <group_list>
          <group group_id="O1">
            <title>Project X 26ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use.&#xD;
Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O2">
            <title>Project X 5.1ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use.&#xD;
Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O3">
            <title>Prevantics Maxi Swabstick</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use.&#xD;
Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Bacterial Microflora on the Inguinal Area</title>
          <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
          <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
          <units>log10 CFU</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>evaluable sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>evaluable sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.92" spread="1.42"/>
                    <measurement group_id="O2" value="-3.69" spread="1.56"/>
                    <measurement group_id="O3" value="-3.94" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Bacterial Microflora on the Inguinal Area</title>
        <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
        <time_frame>10 minutes</time_frame>
        <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
        <group_list>
          <group group_id="O1">
            <title>Project X 26ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use.&#xD;
Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O2">
            <title>Project X 5.1ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use.&#xD;
Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O3">
            <title>Prevantics Maxi Swabstick</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use.&#xD;
Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Bacterial Microflora on the Inguinal Area</title>
          <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
          <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
          <units>log10 CFU</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>evaluable sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>evaluable sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.07" spread="1.62"/>
                    <measurement group_id="O2" value="-4.04" spread="1.61"/>
                    <measurement group_id="O3" value="-4.17" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Bacterial Microflora on the Inguinal Area</title>
        <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
        <time_frame>6 hours</time_frame>
        <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
        <group_list>
          <group group_id="O1">
            <title>Project X 26ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use.&#xD;
Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O2">
            <title>Project X 5.1ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use.&#xD;
Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O3">
            <title>Prevantics Maxi Swabstick</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use.&#xD;
Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Bacterial Microflora on the Inguinal Area</title>
          <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
          <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
          <units>log10 CFU</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>evaluable sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>evaluable sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.30" spread="1.43"/>
                    <measurement group_id="O2" value="-4.57" spread="1.62"/>
                    <measurement group_id="O3" value="-4.28" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Bacterial Microflora on the Abdomen</title>
        <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
        <time_frame>30 seconds</time_frame>
        <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
        <group_list>
          <group group_id="O1">
            <title>Project X 26ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use.&#xD;
Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O2">
            <title>Project X 5.1ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use.&#xD;
Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O3">
            <title>Prevantics Maxi Swabstick</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use.&#xD;
Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Bacterial Microflora on the Abdomen</title>
          <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
          <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
          <units>log10 CFU</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>evaluable sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>evaluable sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.09" spread="0.76"/>
                    <measurement group_id="O2" value="-2.95" spread="1.11"/>
                    <measurement group_id="O3" value="-2.85" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Bacterial Microflora on the Abdomen</title>
        <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
        <time_frame>10 minutes</time_frame>
        <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
        <group_list>
          <group group_id="O1">
            <title>Project X 26ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use.&#xD;
Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O2">
            <title>Project X 5.1ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use.&#xD;
Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O3">
            <title>Prevantics Maxi Swabstick</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use.&#xD;
Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Bacterial Microflora on the Abdomen</title>
          <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
          <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
          <units>log10 CFU</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>evaluable sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>evaluable sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.15" spread="0.85"/>
                    <measurement group_id="O2" value="-2.97" spread="1.06"/>
                    <measurement group_id="O3" value="-3.01" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Bacterial Microflora on the Abdomen</title>
        <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
        <time_frame>6 hours</time_frame>
        <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
        <group_list>
          <group group_id="O1">
            <title>Project X 26ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use.&#xD;
Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O2">
            <title>Project X 5.1ml</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use.&#xD;
Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
          <group group_id="O3">
            <title>Prevantics Maxi Swabstick</title>
            <description>3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use.&#xD;
Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Bacterial Microflora on the Abdomen</title>
          <description>Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention</description>
          <population>The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body).</population>
          <units>log10 CFU</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>evaluable sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>evaluable sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.19" spread="0.87"/>
                    <measurement group_id="O2" value="-3.27" spread="0.95"/>
                    <measurement group_id="O3" value="-3.18" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 months</time_frame>
      <desc>visual assessments of skin irritation and reporting of irritation by subjects</desc>
      <group_list>
        <group group_id="E1">
          <title>Project X 26ml</title>
          <description>3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 26ml volume. Single use.&#xD;
Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
        </group>
        <group group_id="E2">
          <title>Project X 5.1ml</title>
          <description>3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 5.1ml volume. Single use.&#xD;
Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</description>
        </group>
        <group group_id="E3">
          <title>Prevantics Maxi Swabstick</title>
          <description>3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use.&#xD;
Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects</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="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
              </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="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Commercial Manager</name_or_title>
      <organization>Eurofins EVIC</organization>
      <phone>40 213357090</phone>
      <email>luciachirita@eurofins.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/NCT03817580
org study id: ER18/282
nct id: NCT03817580
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml Project X, 5.1ml Project
      X and Prevantics® Maxi Swabstick following ASTM E1173 - Standard Test Method for Evaluation
      of Preoperative, Precatheterization, or Preinjection Skin Preparations, ASTM International,
      West Conshohocken, PA, 2015,
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
masking description: Samples are blinded to the participant and technical team.
measure: Change in Bacterial Microflora on the Inguinal Area
time frame: 30 seconds
description: Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention
measure: Change in Bacterial Microflora on the Inguinal Area
time frame: 10 minutes
description: Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention
measure: Change in Bacterial Microflora on the Inguinal Area
time frame: 6 hours
description: Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention
measure: Change in Bacterial Microflora on the Abdomen
time frame: 30 seconds
description: Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention
measure: Change in Bacterial Microflora on the Abdomen
time frame: 10 minutes
description: Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention
measure: Change in Bacterial Microflora on the Abdomen
time frame: 6 hours
description: Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention
arm group label: Project X 26ml
arm group type: Experimental
description: 3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 26ml volume. Single use.
arm group label: Project X 5.1ml
arm group type: Experimental
description: 3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use.
arm group label: Prevantics Maxi Swabstick
arm group type: Active Comparator
description: 3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use.
intervention type: Drug
intervention name: Project X 26ml
description: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
arm group label: Project X 26ml
intervention type: Drug
intervention name: Project X 5.1ml
description: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
arm group label: Project X 5.1ml
intervention type: Drug
intervention name: Prevantics Maxi Swabstick
description: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
arm group label: Prevantics Maxi Swabstick
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rozalia Olsavszky, MD
role: Principal Investigator
affiliation: EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L
facility: 
country: Romania
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 