<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/NCT02210208</url>
  </required_header>
  <id_info>
    <org_study_id>MpTAg03</org_study_id>
    <nct_id>NCT02210208</nct_id>
  </id_info>
  <brief_title>A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.</brief_title>
  <acronym>MpTAg03</acronym>
  <official_title>An Open, Non-controlled, Multi-centre, Clinical Investigation to Verify Performance and Safety of a Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients and the Usefulness of a Marketed Donor Site Dressing.</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>
      Part A The primary objective of Part A will be to verify performance and safety of Mepitel®&#xD;
      Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the&#xD;
      treatment of skin grafts in surgical burn patients.&#xD;
&#xD;
      Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer&#xD;
      Ag as an adequate option for donor site healing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This post market clinical follow-up investigation is designed as an open, non-controlled,&#xD;
      multi- centre, clinical investigation.&#xD;
&#xD;
      A total of approximately 25 subjects from among 4-6 clinical investigative sites will be&#xD;
      evaluated providing they fulfill all the inclusion criteria and none of the exclusion&#xD;
      criteria. A signed and dated informed consent/assent will be obtained for all subjects.&#xD;
&#xD;
      Subjects to be included will present with a thermal burn injury that will require skin&#xD;
      grafting and result in a donor site. Overall percent Total Body Surface Area (%TBSA) burned&#xD;
      will not exceed 30%.&#xD;
&#xD;
      The subjects will be consecutively allocated to a subject code providing they fulfill all&#xD;
      inclusion criteria and none of the exclusion criteria and have signed a written consent.&#xD;
&#xD;
      The subjects were participating in the study for 14 days postop.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 15, 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two Parts (part A and B) with one dressing device for the skin graft placed on a surgical burn wound and another dressing device placed on the donor site.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part A: Number of Participants With Healing</measure>
    <time_frame>14 days</time_frame>
    <description>Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B</measure>
    <time_frame>14 days with 2 visits</time_frame>
    <description>Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part A Secondary Outcome.</measure>
    <time_frame>14 days with 2 visits</time_frame>
    <description>Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit.&#xD;
Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B Secondary Outcome.</measure>
    <time_frame>14 days with 2 visits</time_frame>
    <description>Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Burn Injury</condition>
  <condition>Skin Graft</condition>
  <arm_group>
    <arm_group_label>Mepitel® Ag</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A dressing device used for surgical burn wounds with skin graft.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mepilex® Transfer Ag</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Donor site dressing device in the very same patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mepitel® Ag</intervention_name>
    <description>A soft silicone wound contact layer that allows exudates to pass vertically into a secondary absorbent dressing. The product provides fixation and protection of the tissues and has antimicrobial properties.&#xD;
This silicone net dressing will be used to prevent lifting and adherence of skin grafts to the dressings, as well as to prevent pain, and promote healing.</description>
    <arm_group_label>Mepitel® Ag</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mepilex® Transfer Ag</intervention_name>
    <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 consists of a Safetac® adhesive layer and compressed polyurethane foam containing silver sulphate and activated carbon. Safetac® is a unique adhesive technology that minimizes pain to patients and trauma to wounds and the surrounding skin. It minimizes risk for maceration by sealing the wound margins; ensuring exudate does not spread to the surrounding skin.</description>
    <arm_group_label>Mepilex® Transfer Ag</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Part A&#xD;
&#xD;
        Inclusion Criteria&#xD;
&#xD;
          -  Subjects with burn injury resulting in up to 30% TBSA&#xD;
&#xD;
          -  Full thickness area of burn should not be more than 20%&#xD;
&#xD;
          -  Area in need of skin grafting can be 1-15% TBSA&#xD;
&#xD;
          -  Study site area must have healthy, intact peri-wound skin surrounding it to allow for&#xD;
             adequate overlap of study product&#xD;
&#xD;
          -  Thermal injuries only&#xD;
&#xD;
          -  Subjects age 18 months to &lt; 65 years.&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  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;
          -  Greater than 30% TBSA&#xD;
&#xD;
          -  Full thickness areas greater than 20% TBSA&#xD;
&#xD;
          -  Full thickness area to be grafted less than 1%&#xD;
&#xD;
          -  Presence of respiratory involvement&#xD;
&#xD;
          -  Subjects on mechanical ventilation&#xD;
&#xD;
          -  Subjects with infected burn wounds&#xD;
&#xD;
          -  Subjects with organ failure&#xD;
&#xD;
          -  Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe aeaemia) judged by&#xD;
             the investigator to be a potential interference in the treatment&#xD;
&#xD;
          -  Subjects treated with systemic glucocorticosteroids, except patients taking occasional&#xD;
             doses or doses less than 10mg prednisolone/day or equivalent&#xD;
&#xD;
          -  Known allergy/hypersensitivity to any of the components of the investigation products.&#xD;
&#xD;
          -  Subjects with physical and/or mental conditions that are not expected to comply with&#xD;
             the investigation, including patients totally confined to bed&#xD;
&#xD;
          -  Participation in other clinical investigation(s) within 1 month prior to start of the&#xD;
             investigation&#xD;
&#xD;
          -  Previous randomized to this investigation&#xD;
&#xD;
        Part B&#xD;
&#xD;
        Inclusion Criteria&#xD;
&#xD;
        -There must be healthy, intact peri-wound skin surrounding the planned donor site to allow&#xD;
        for adequate overlap of study product (5 cm)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Investigator do not agree to treat the donor site with Mepilex Transfer Ag&#xD;
&#xD;
          -  The subject do not agree to participate in the donor site part&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Glat, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Drexel University College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Arizona Burn Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of South Florida Board of Trustees</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32886-4687</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Plastic Surgical Group</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Chrisopher's Hospital for Children</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <results_first_submitted>July 5, 2017</results_first_submitted>
  <results_first_submitted_qc>July 5, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 2, 2017</results_first_posted>
  <last_update_submitted>December 12, 2017</last_update_submitted>
  <last_update_submitted_qc>December 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2018</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>Burns</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Overall Study</title>
          <description>Mepitel® Ag treatment on graft covered wounds 25 patients. Mepilex® Transfer Ag treatment on donor site 19 patients</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period A (Graft Site)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician decided not to graft at OR</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period B (Donor Site)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19">6 subjects was decided by the Physician not to be included in the Part B.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>7 subjects healed at or before Day 14</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>ITT population</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a &quot;Donor site&quot; to help the burn wound heal. The &quot;Donor site&quot; was also treated and these patients were included i part B.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Participants in Part A=25 and Participants in Part B=19. Every patient in Part A was not eligible for Part B.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.6" lower_limit="1" upper_limit="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.9" lower_limit="3" upper_limit="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a &quot;Donor site&quot; to help the burn wound heal. The &quot;Donor site&quot; was also treated and these patients were included i part B.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Part A: Number of Participants With Healing</title>
        <description>Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).</description>
        <time_frame>14 days</time_frame>
        <population>ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Mepitel Ag</title>
            <description>Mepitel Ag treatment on burn wounds with skin grafts&#xD;
Mepitel Ag</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Number of Participants With Healing</title>
          <description>Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).</description>
          <population>ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B.</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="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7: Graft take healed ≥95%=No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Graft take healed ≥95%=Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Graft take healed ≥95%=No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Graft take healed ≥95%=Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part B</title>
        <description>Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).</description>
        <time_frame>14 days with 2 visits</time_frame>
        <population>ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Mepilex Transfer Ag</title>
            <description>Mepilex Transfer Ag treatment at donor site for skin graft.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B</title>
          <description>Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).</description>
          <population>ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B.</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="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7: Donor site healed ≥95%=No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Donor site healed ≥95%=Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Graft take/Donor site healed ≥95%=No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Donor site healed ≥95%=Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A Secondary Outcome.</title>
        <description>Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit.&#xD;
Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing.</description>
        <time_frame>14 days with 2 visits</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Mepitel Ag</title>
            <description>Mepitel Ag treatment on skin graft over surgical burn wounds.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A Secondary Outcome.</title>
          <description>Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit.&#xD;
Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing.</description>
          <population>ITT population</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="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7: Was a product removal performed: Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Was there any adherence to the graft: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Was there any adherence to the graft: Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Graft lift off with removal of product: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Graft lift off with removal of product: Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Was there any adherence to the graft: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Was there any adherence to the graft: Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B Secondary Outcome.</title>
        <description>Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.</description>
        <time_frame>14 days with 2 visits</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Mepilex Transfer Ag</title>
            <description>Mepilex Transfer Ag treatment at donor site for skin graft.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B Secondary Outcome.</title>
          <description>Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.</description>
          <population>ITT population</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="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7: Was adherence of product assessed: No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Was adherence of product assessed: Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Was removal assessment performed: Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Did product stick to donor site: No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Did product stick to donor site: Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Was adherence of product assessed: Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Was removal assessment performed: Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Did product stick to donor site: No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Overall Study</title>
          <description>Mepitel Ag treatment and Mepilex Transfer Ag</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="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>leukocytosis</sub_title>
                <description>leukosytosis potential from allografted area of burn</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>hypocalcemia</sub_title>
                <description>hypocalcemia</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>hypermagnesemia</sub_title>
                <description>hypermagnesemia</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>hyperphosphatemia</sub_title>
                <description>hyperphosphatemia</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>hypertension</sub_title>
                <description>hypertension</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>high blood pressure</sub_title>
                <description>post-op high blood pressure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>infection</sub_title>
                <description>suspected infection at graft site</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>infection</sub_title>
                <description>suspected infection at donor site</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>muscle spasm</sub_title>
                <description>muscle spasm</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>femoral artery IV site infiltrated</sub_title>
                <description>femoral artery IV site infiltrated</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Research Director</name_or_title>
      <organization>Mölnlycke Health Care</organization>
      <phone>+46 31 722 30 00</phone>
      <email>info@monlycke.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/NCT02210208
org study id: MpTAg03
nct id: NCT02210208
lead sponsor: 
has dmc: No
Part A The primary objective of Part A will be to verify performance and safety of Mepitel®
      Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the
      treatment of skin grafts in surgical burn patients.

      Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer
      Ag as an adequate option for donor site healing.
This post market clinical follow-up investigation is designed as an open, non-controlled,
      multi- centre, clinical investigation.

      A total of approximately 25 subjects from among 4-6 clinical investigative sites will be
      evaluated providing they fulfill all the inclusion criteria and none of the exclusion
      criteria. A signed and dated informed consent/assent will be obtained for all subjects.

      Subjects to be included will present with a thermal burn injury that will require skin
      grafting and result in a donor site. Overall percent Total Body Surface Area (%TBSA) burned
      will not exceed 30%.

      The subjects will be consecutively allocated to a subject code providing they fulfill all
      inclusion criteria and none of the exclusion criteria and have signed a written consent.

      The subjects were participating in the study for 14 days postop.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Two Parts (part A and B) with one dressing device for the skin graft placed on a surgical burn wound and another dressing device placed on the donor site.
primary purpose: Treatment
masking: None (Open Label)
measure: Part A: Number of Participants With Healing
time frame: 14 days
description: Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).
measure: Part B
time frame: 14 days with 2 visits
description: Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).
measure: Part A Secondary Outcome.
time frame: 14 days with 2 visits
description: Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit.
Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing.
measure: Part B Secondary Outcome.
time frame: 14 days with 2 visits
description: Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.
arm group label: Mepitel® Ag
arm group type: Experimental
description: A dressing device used for surgical burn wounds with skin graft.
arm group label: Mepilex® Transfer Ag
arm group type: Experimental
description: Donor site dressing device in the very same patient.
intervention type: Device
intervention name: Mepitel® Ag
description: A soft silicone wound contact layer that allows exudates to pass vertically into a secondary absorbent dressing. The product provides fixation and protection of the tissues and has antimicrobial properties.
This silicone net dressing will be used to prevent lifting and adherence of skin grafts to the dressings, as well as to prevent pain, and promote healing.
arm group label: Mepitel® Ag
intervention type: Device
intervention name: Mepilex® Transfer Ag
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.
Mepilex® Transfer Ag consists of a Safetac® adhesive layer and compressed polyurethane foam containing silver sulphate and activated carbon. Safetac® is a unique adhesive technology that minimizes pain to patients and trauma to wounds and the surrounding skin. It minimizes risk for maceration by sealing the wound margins; ensuring exudate does not spread to the surrounding skin.
arm group label: Mepilex® Transfer Ag
criteria: 
gender: All
minimum age: 18 Months
maximum age: 65 Years
healthy volunteers: No
last name: Paul Glat, Professor
role: Principal Investigator
affiliation: Drexel University College of Medicine
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Burns
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 