<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/NCT01670201</url>
  </required_header>
  <id_info>
    <org_study_id>MxT Ag 01</org_study_id>
    <nct_id>NCT01670201</nct_id>
  </id_info>
  <brief_title>An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients</brief_title>
  <official_title>A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Adequacy of a New Donor Site Dressing in Surgical Burn Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Molnlycke Health Care AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Molnlycke Health Care AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator will identify the test donor site and test location will be considered on&#xD;
      the upper anterior thighs as being the most suitable if available. Circumferential donors&#xD;
      will be considered acceptable as well.&#xD;
&#xD;
      Treatment will be initiated in the operation room following debridement and split thickness&#xD;
      grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and&#xD;
      dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked&#xD;
      lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be&#xD;
      applied directly to study site. Secondary dressing will include covering with ace wrap.&#xD;
&#xD;
      Healing should be asses after 10-14 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, open, non-controlled clinical investigation to evaluate the adequacy of donor&#xD;
      site healing when using a new donor site dressing, Mepilex Transfer Ag approximately 20&#xD;
      subjects from 2 centres in the US, presenting with the need for surgical intervention and&#xD;
      grafting for burn injury will be enrolled. Eligible subjects will have a selected donor site&#xD;
      designated as a &quot;study site&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Had &gt; 95 % Epithelialization at Day 10</measure>
    <time_frame>10 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain at Dressing Changes</measure>
    <time_frame>28 days</time_frame>
    <description>The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days.&#xD;
Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS),&#xD;
Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Donor Site Complication</condition>
  <arm_group>
    <arm_group_label>Mepilex Transfer Ag</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mepilex Transfer Ag</intervention_name>
    <description>Silver dressing</description>
    <arm_group_label>Mepilex Transfer Ag</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Surgical donor sites for deep partial-thickness or full-thickness burns&#xD;
&#xD;
          2. Burn of thermal origin&#xD;
&#xD;
          3. Both genders with an age ≥ 7 years at enrolment&#xD;
&#xD;
          4. Signed informed consent&#xD;
&#xD;
          5. Subjects who are younger than the legal consenting age must in addition to their own&#xD;
             assent form have a signature from a legally authorized representative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any known or suspected systemic infection&#xD;
&#xD;
          2. Any known sensitivity to silver or other components/products used in this study.&#xD;
&#xD;
          3. Any active, uncontrolled, progressive or untreated malignancy. A subject who has had a&#xD;
             malignant disease in the past, was treated with the expectation of a cure and is&#xD;
             currently disease-free, may be considered for study entry.&#xD;
&#xD;
          4. Use of penicillamine, corticosteroid or immunosuppressive medication within 2 months&#xD;
             prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which&#xD;
             cannot be discontinued, or who is likely to be prescribed these medications or any&#xD;
             other medications known to adversely affect wound healing during study participation.&#xD;
&#xD;
          5. Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or&#xD;
             endocrinologic disorders.&#xD;
&#xD;
          6. Requires immersion hydrotherapy at any time during study participation (note,&#xD;
             showering hydrotherapy is allowed).&#xD;
&#xD;
          7. Subject unwilling to comply with 28 day follow-up.&#xD;
&#xD;
          8. Participation in another investigational study while participating in this study.&#xD;
&#xD;
          9. Bleeding disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole Gibran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UW Medicine Regional Burn Center Seattle, WA 98104</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LongIsland Plastic Surgical Group, PC</name>
      <address>
        <city>Garden City</city>
        <state>New York</state>
        <zip>11530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>June 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <results_first_submitted>April 3, 2014</results_first_submitted>
  <results_first_submitted_qc>September 3, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 10, 2014</results_first_posted>
  <last_update_submitted>September 3, 2014</last_update_submitted>
  <last_update_submitted_qc>September 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mepilex Transfer Ag</title>
          <description>Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.&#xD;
Mepilex Transfer Ag: Silver dressing</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mepilex Transfer Ag</title>
          <description>Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.&#xD;
Mepilex Transfer Ag: Silver dressing</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Pain at Dressing Changes</title>
        <description>The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days.&#xD;
Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS),&#xD;
Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mepilex Transfer Ag</title>
            <description>Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.&#xD;
Mepilex Transfer Ag: Silver dressing</description>
          </group>
        </group_list>
        <measure>
          <title>Pain at Dressing Changes</title>
          <description>The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days.&#xD;
Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS),&#xD;
Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst.</description>
          <units>units on a scale VAS 0-100</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="0" upper_limit="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Had &gt; 95 % Epithelialization at Day 10</title>
        <time_frame>10 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mepilex Transfer Ag</title>
            <description>Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.&#xD;
Mepilex Transfer Ag: Silver dressing</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had &gt; 95 % Epithelialization at Day 10</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Mepilex Transfer Ag</title>
          <description>Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.&#xD;
Mepilex Transfer Ag: Silver dressing</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Worsening disruption of wound healing</sub_title>
                <description>Worsening disruption of wound healing</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </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="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Infection to donor site</sub_title>
                <description>Infection to donor site</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Nicole Gibran</name_or_title>
      <organization>Harborview Medical Center / Seattle, Washington</organization>
      <phone>206-744-3140</phone>
      <email>nicoleg@uw.edu</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/NCT01670201
org study id: MxT Ag 01
nct id: NCT01670201
lead sponsor: 
has dmc: No
The investigator will identify the test donor site and test location will be considered on
      the upper anterior thighs as being the most suitable if available. Circumferential donors
      will be considered acceptable as well.

      Treatment will be initiated in the operation room following debridement and split thickness
      grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and
      dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked
      lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be
      applied directly to study site. Secondary dressing will include covering with ace wrap.

      Healing should be asses after 10-14 days.
A prospective, open, non-controlled clinical investigation to evaluate the adequacy of donor
      site healing when using a new donor site dressing, Mepilex Transfer Ag approximately 20
      subjects from 2 centres in the US, presenting with the need for surgical intervention and
      grafting for burn injury will be enrolled. Eligible subjects will have a selected donor site
      designated as a "study site".
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Who Had > 95 % Epithelialization at Day 10
time frame: 10 days
measure: Pain at Dressing Changes
time frame: 28 days
description: The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days.
Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS),
Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst.
arm group label: Mepilex Transfer Ag
arm group type: Experimental
description: Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
intervention type: Device
intervention name: Mepilex Transfer Ag
description: Silver dressing
arm group label: Mepilex Transfer Ag
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Nicole Gibran, MD
role: Principal Investigator
affiliation: UW Medicine Regional Burn Center Seattle, WA 98104
facility: 
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 