<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/NCT03756506</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01</org_study_id>
    <nct_id>NCT03756506</nct_id>
  </id_info>
  <brief_title>The Use of a Novel Microbicidal Liquid Polymer for the Reduction of Pin Track Infection</brief_title>
  <official_title>An Evaluation of the Use of a Novel Microbicidal Liquid Polymer for the Reduction of Pin-tract Infection in Research Participants Receiving External Fixation Following Deformity Correction and Traumatic Provisional Fixation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prevent-Plus LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prevent-Plus LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate additional clinical uses for the polymer, which is&#xD;
      a FDA approved, 510k, medical device, but has not been approved for use on patients with pin&#xD;
      track sites as a way to lower the infection rate and is investigational for this purpose. The&#xD;
      approved uses include wound care and post-operative care.&#xD;
&#xD;
      About 13 subjects will take part in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Objectives Research participants eligible for the study will be those undergoing&#xD;
      Deformity Correction and Traumatic Provisional Fixation. These research participants have a&#xD;
      number of pins placed to ensure this required rigid fixation. The number of external fixation&#xD;
      pins averages approximately ten per research participant.&#xD;
&#xD;
      It is a 510K FDA cleared medical device indicated for providing a covering over minor wounds&#xD;
      and scrapes that are clean and dry. The microbicidal liquid solution consists of organic&#xD;
      polymer dissolved in methylene chloride organic solvent. The unique formulation eradicates&#xD;
      any organisms (bacteria, fungi, viruses) it comes in contact with. This is a result of the&#xD;
      methylene chloride's activity against an infinite number of organisms. The methylene chloride&#xD;
      evaporates leaving a clear, elastomeric, non-odorous film for covering minor wounds. The film&#xD;
      protects the wound against entry of water, dirt, and germs. The film is elastomeric and&#xD;
      protects in difficult regions where flexing, bending and creasing skin occurs. The clear film&#xD;
      forms in less than a minute. Application is commonly accomplished using a cotton tip&#xD;
      applicator. The liquid is applied on and around the wound extending at least an inch and a&#xD;
      quarter beyond the edges of the wound. Momentary stinging may occur upon initial application.&#xD;
      The film commonly remains intact for one to three days or longer depending on exposure to&#xD;
      rubbing, flexing, or soap and water. This film is resistant to degradation by water alone,&#xD;
      but can be easily removed with the combination of soap and water or it can be gently peeled&#xD;
      off starting at the outer edges. It is for external use only. It is not intended for use on&#xD;
      deep or infected wounds or puncture wounds, or for use near the eyes, mouth, or nose.&#xD;
      Intentional inhaling of the contents may be harmful or fatal. The bottle should be tightly&#xD;
      capped after each use to prevent evaporation of the solvent.7&#xD;
&#xD;
      This Principle Investigator has previously utilized and topically applied the product as an&#xD;
      additional step in the treatment protocol for pin site care for several reconstructive&#xD;
      surgery patients (approximately 25) with over 200 pin sites with only 2 pin site infections.&#xD;
      This represents a significant reduction from the average incidence of pin site infections&#xD;
      reported in the literature (&lt;1% vs 27% on a per research participant basis). A recently&#xD;
      published retrospective case series evaluating this microbicidal polymer dressing reported 6&#xD;
      patients and 66 pins had no infections when Duraderm® was used as part of their pin site care&#xD;
      regimen.8&#xD;
&#xD;
      This study was undertaken to formally evaluate whether this microbial liquid po used on pin&#xD;
      sites leads to a reduction in pin track infections when compared to a control group as well&#xD;
      as the reported average incidence in the literature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>The study will enroll 12 total research participants (6 control research participants and 6 research participants) with approximately 120 pin sites (approximately 60 in the Control group and 60 in the DuraDerm® group). Each research participant undergoing Deformity Correction and/or Traumatic Provisional Surgery will be asked to participate in the study to evaluate if the topical application of a Novel Microbicidal Liquid Polymer as an additional step in the management of post-operative pin track site care reduces the incidence of pin track infections. Investigational Review Board (IRB) approval will be obtained and informed research participant consent will be obtained from each research participant.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pin Track Infection Rate Among Research Participants Based on Number of Pins Undergoing Deformity Correction and Traumatic Provisional Fixation</measure>
    <time_frame>10 months</time_frame>
    <description>Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pin Track Infection Rate Among Research Participants Undergoing Deformity Correction and Traumatic Provisional Fixation</measure>
    <time_frame>10 months</time_frame>
    <description>Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Infection</condition>
  <condition>Post-operative Care</condition>
  <arm_group>
    <arm_group_label>Novel Microbicidal Liquid Polymer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge,tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.&#xD;
Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply product with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. The Polymer will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group: no Novel Microbicidal Liquid Polymer</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.&#xD;
Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.&#xD;
Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Novel Microbicidal Liquid Polymer</intervention_name>
    <description>The polymer is a 510K FDA cleared medical device indicated for providing a covering over minor wounds and scrapes that are clean and dry. The microbicidal liquid solution consists of organic polymers . The unique formulation eradicates any organisms (bacteria, fungi, viruses) it comes in contact with. This is a result of the solvent's activity against an infinite number of organisms After eradication is complete, the solvent then transitions into a clear, elastomeric, non-odorous film for covering disrupted tissue. The film protects the wound against entry of water, dirt, and germs. The film is elastomeric and protects in difficult regions where flexing, bending and creasing skin occurs. The clear film forms in less than a minute.6 DuraDerm® should not be used to the treat deep infected wounds. DuraDerm® can be used to protect disrupted skin surface of wounds that are clean and dry.</description>
    <arm_group_label>Novel Microbicidal Liquid Polymer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Deformity correction, traumatic provisional fixation&#xD;
&#xD;
          2. All pin sites are stable&#xD;
&#xD;
          3. 18 years of age or greater&#xD;
&#xD;
          4. No known contraindication to receive product&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age less than 18 years&#xD;
&#xD;
          2. Known allergy to Methylene Chloride&#xD;
&#xD;
          3. Known sensitivity to organic polymers&#xD;
&#xD;
          4. Non-clean, dry wound at pin&#xD;
&#xD;
          5. Vulnerable research participants (Institutionalized, students, employees, prisoners,&#xD;
             or those with decisional incapacity, etc.)&#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>Shital Pema, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kettering Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Julie Morris</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>February 7, 2020</results_first_submitted>
  <results_first_submitted_qc>June 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 13, 2020</results_first_posted>
  <last_update_submitted>March 8, 2021</last_update_submitted>
  <last_update_submitted_qc>March 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_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>October 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03756506/Prot_000.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>December 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03756506/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>dlk</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>DuraDerm® Group</title>
          <description>All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge,tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.&#xD;
Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.</description>
        </group>
        <group group_id="P2">
          <title>Control Group: no DuraDerm</title>
          <description>The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.&#xD;
Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.&#xD;
Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>DuraDerm® Group</title>
          <description>All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge.&#xD;
Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.</description>
        </group>
        <group group_id="B2">
          <title>Control Group: no DuraDerm</title>
          <description>The usual care of pin track sites will be followed as outlined below. All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.&#xD;
Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.&#xD;
Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.</description>
        </group>
        <group group_id="B3">
          <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="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pin Track Infection Rate Among Research Participants Based on Number of Pins Undergoing Deformity Correction and Traumatic Provisional Fixation</title>
        <description>Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.</description>
        <time_frame>10 months</time_frame>
        <population>Infection rate was analyzed on a per patient and a per pin basis.</population>
        <group_list>
          <group group_id="O1">
            <title>DuraDerm® Patient Group</title>
            <description>All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge,tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.&#xD;
Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.</description>
          </group>
          <group group_id="O2">
            <title>Patient Control Group: no DuraDerm</title>
            <description>The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.&#xD;
Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.&#xD;
Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.</description>
          </group>
        </group_list>
        <measure>
          <title>Pin Track Infection Rate Among Research Participants Based on Number of Pins Undergoing Deformity Correction and Traumatic Provisional Fixation</title>
          <description>Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.</description>
          <population>Infection rate was analyzed on a per patient and a per pin basis.</population>
          <units>Pins</units>
          <param>Count of Units</param>
          <units_analyzed>Pins</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Pins</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pin Track Infection Rate Among Research Participants Undergoing Deformity Correction and Traumatic Provisional Fixation</title>
        <description>Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.</description>
        <time_frame>10 months</time_frame>
        <population>Infection rate was analyzed on a per patient basis.</population>
        <group_list>
          <group group_id="O1">
            <title>DuraDerm® Patient Group</title>
            <description>All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge,tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.&#xD;
Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.</description>
          </group>
          <group group_id="O2">
            <title>Patient Control Group: no DuraDerm</title>
            <description>The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.&#xD;
Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.&#xD;
Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.</description>
          </group>
        </group_list>
        <measure>
          <title>Pin Track Infection Rate Among Research Participants Undergoing Deformity Correction and Traumatic Provisional Fixation</title>
          <description>Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.</description>
          <population>Infection rate was analyzed on a per patient basis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected over a period of 4-8 weeks depending on patient's length of pin placement.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>DuraDerm® Group</title>
          <description>All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge.&#xD;
Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.</description>
        </group>
        <group group_id="E2">
          <title>Control Group: no DuraDerm</title>
          <description>The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.&#xD;
Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.&#xD;
Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.</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="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </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="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </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>
    <limitations_and_caveats>This study is limited by its sample size when evaluating infection rate on a per patient basis.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jeff Elbl</name_or_title>
      <organization>Prevent-Plus</organization>
      <phone>314-606-5046</phone>
      <email>jeff.elbl@prevent-plus.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/NCT03756506
org study id: 2018-01
nct id: NCT03756506
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of the study is to investigate additional clinical uses for the polymer, which is
      a FDA approved, 510k, medical device, but has not been approved for use on patients with pin
      track sites as a way to lower the infection rate and is investigational for this purpose. The
      approved uses include wound care and post-operative care.

      About 13 subjects will take part in this study.
Study Objectives Research participants eligible for the study will be those undergoing
      Deformity Correction and Traumatic Provisional Fixation. These research participants have a
      number of pins placed to ensure this required rigid fixation. The number of external fixation
      pins averages approximately ten per research participant.

      It is a 510K FDA cleared medical device indicated for providing a covering over minor wounds
      and scrapes that are clean and dry. The microbicidal liquid solution consists of organic
      polymer dissolved in methylene chloride organic solvent. The unique formulation eradicates
      any organisms (bacteria, fungi, viruses) it comes in contact with. This is a result of the
      methylene chloride's activity against an infinite number of organisms. The methylene chloride
      evaporates leaving a clear, elastomeric, non-odorous film for covering minor wounds. The film
      protects the wound against entry of water, dirt, and germs. The film is elastomeric and
      protects in difficult regions where flexing, bending and creasing skin occurs. The clear film
      forms in less than a minute. Application is commonly accomplished using a cotton tip
      applicator. The liquid is applied on and around the wound extending at least an inch and a
      quarter beyond the edges of the wound. Momentary stinging may occur upon initial application.
      The film commonly remains intact for one to three days or longer depending on exposure to
      rubbing, flexing, or soap and water. This film is resistant to degradation by water alone,
      but can be easily removed with the combination of soap and water or it can be gently peeled
      off starting at the outer edges. It is for external use only. It is not intended for use on
      deep or infected wounds or puncture wounds, or for use near the eyes, mouth, or nose.
      Intentional inhaling of the contents may be harmful or fatal. The bottle should be tightly
      capped after each use to prevent evaporation of the solvent.7

      This Principle Investigator has previously utilized and topically applied the product as an
      additional step in the treatment protocol for pin site care for several reconstructive
      surgery patients (approximately 25) with over 200 pin sites with only 2 pin site infections.
      This represents a significant reduction from the average incidence of pin site infections
      reported in the literature (<1% vs 27% on a per research participant basis). A recently
      published retrospective case series evaluating this microbicidal polymer dressing reported 6
      patients and 66 pins had no infections when Duraderm® was used as part of their pin site care
      regimen.8

      This study was undertaken to formally evaluate whether this microbial liquid po used on pin
      sites leads to a reduction in pin track infections when compared to a control group as well
      as the reported average incidence in the literature.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study will enroll 12 total research participants (6 control research participants and 6 research participants) with approximately 120 pin sites (approximately 60 in the Control group and 60 in the DuraDerm® group). Each research participant undergoing Deformity Correction and/or Traumatic Provisional Surgery will be asked to participate in the study to evaluate if the topical application of a Novel Microbicidal Liquid Polymer as an additional step in the management of post-operative pin track site care reduces the incidence of pin track infections. Investigational Review Board (IRB) approval will be obtained and informed research participant consent will be obtained from each research participant.
primary purpose: Prevention
masking: Single (Care Provider)
measure: Pin Track Infection Rate Among Research Participants Based on Number of Pins Undergoing Deformity Correction and Traumatic Provisional Fixation
time frame: 10 months
description: Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.
measure: Pin Track Infection Rate Among Research Participants Undergoing Deformity Correction and Traumatic Provisional Fixation
time frame: 10 months
description: Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.
arm group label: Novel Microbicidal Liquid Polymer
arm group type: Active Comparator
description: All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge,tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.
Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply product with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. The Polymer will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.
arm group label: Control group: no Novel Microbicidal Liquid Polymer
arm group type: No Intervention
description: The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.
Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.
Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.
intervention type: Device
intervention name: Novel Microbicidal Liquid Polymer
description: The polymer is a 510K FDA cleared medical device indicated for providing a covering over minor wounds and scrapes that are clean and dry. The microbicidal liquid solution consists of organic polymers . The unique formulation eradicates any organisms (bacteria, fungi, viruses) it comes in contact with. This is a result of the solvent's activity against an infinite number of organisms After eradication is complete, the solvent then transitions into a clear, elastomeric, non-odorous film for covering disrupted tissue. The film protects the wound against entry of water, dirt, and germs. The film is elastomeric and protects in difficult regions where flexing, bending and creasing skin occurs. The clear film forms in less than a minute.6 DuraDerm® should not be used to the treat deep infected wounds. DuraDerm® can be used to protect disrupted skin surface of wounds that are clean and dry.
arm group label: Novel Microbicidal Liquid Polymer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shital Pema, DPM
role: Principal Investigator
affiliation: Kettering Health System
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study is limited by its sample size when evaluating infection rate on a per patient basis.
point of contact: 