<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/NCT01734317</url>
  </required_header>
  <id_info>
    <org_study_id>MxT Ag 02</org_study_id>
    <nct_id>NCT01734317</nct_id>
  </id_info>
  <brief_title>An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.</brief_title>
  <official_title>An Open, Non Controled, Single-centre, Clinical Investigation to Evaluate Efficacy in Second Degree (Superficial, Deep or Mixed) Partial Thickness Burns When Using a Soft Silicone Wound Contact Ayer Containing Silver.</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>
      Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or&#xD;
      the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or&#xD;
      superficial deep-partial-thickness. The subject will be assessed once a week for a maximum of&#xD;
      3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex Transfer&#xD;
      Ag will be used as wound contact layer and gauze rolls and compression as second dressing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 10 subjects from one site will be evaluated provided they fulfill the inclusion&#xD;
      criteria and none of the exclusion criteria and gives a signed and dated consent.&#xD;
&#xD;
      Subjects may have sustained a burn injury covering 1-25% of the Total Body Surface Area&#xD;
      (TBSA)and assessed as superficial partial-thickness or superficial deep-partial thickness in&#xD;
      dept. Each subject will be followed one time per week for a maximum of 3 weeks or until the&#xD;
      burn is healed if that occurs earlier. Healing is defined as ≥95% epithelialisation. Percent&#xD;
      (%) healed epithelialization will be measured by photo analysing using the PictZar program.&#xD;
      Dressing changes will be performed at each visit and in between if deemed necessary by the&#xD;
      investigator.Gauze rolls and compression will be used as secondary dressing.All dressing&#xD;
      changes will be registered in a log. Pain before, during and after removal will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 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>Number of Participants With Wound Healing</measure>
    <time_frame>14 days and 21 days</time_frame>
    <description>Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. (&quot;The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.&quot;) Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline (Visit 1) Pain Will be Measured Before Burn Assessment Visit 2-3, Pain Will be Measured (Pain BEFORE Dressing Removal, DURING Dressing Removal, AFTER Dressing Removal, 30 Min After Removal</measure>
    <time_frame>After 0/14/21 days treatment</time_frame>
    <description>Pain will be measured by using the VAS scale, by placing a vertical mark across the 100 mm long horizontal line, from No pain to the left to Most intense pain imaginable to the right.&#xD;
Baseline (Visit 1) Pain will be measured before burn assessment Visit 2-4, Pain will be measured (Pain BEFORE dressing removal, DURING dressing removal, AFTER dressing removal, 30 min after removal</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Wound Healing</condition>
  <arm_group>
    <arm_group_label>Dressing</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>A soft silicone wound contact layer.</description>
    <arm_group_label>Dressing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject with a second degree (superficial, deep or mixed) partial thickness burn from&#xD;
             1-25% TBSA.&#xD;
&#xD;
          -  One single, isolated burn area selected for study site Study site area should be&#xD;
             between 1-15% BSA&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  From 18 years and above&#xD;
&#xD;
          -  Either in- or out-patient&#xD;
&#xD;
          -  Thermal burn injury&#xD;
&#xD;
          -  Signed Informed Consent/Assent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Electrical, chemical burn etiology&#xD;
&#xD;
          -  If any full thickness areas are present, these should not be &gt; 5 %&#xD;
&#xD;
          -  Burn greater than 36 hrs old&#xD;
&#xD;
          -  Burns to face&#xD;
&#xD;
          -  Use of chemical/enzymatic and biological debridement within 7 days of investigation&#xD;
             start&#xD;
&#xD;
          -  Presence of inflammation or infection in burn wounds&#xD;
&#xD;
          -  Use of topical antibiotics, antiseptics, or antimicrobials in conjunction with study&#xD;
             product.&#xD;
&#xD;
          -  Subjects with lung injury or Subject being on a ventilator&#xD;
&#xD;
          -  Subjects with dermatologic skin disorders or necrotizing processes&#xD;
&#xD;
          -  Subjects with insulin dependent diabetes mellitus judged by the investigator to be a&#xD;
             potential interference in the treatment&#xD;
&#xD;
          -  Diagnosed underlying disease(s) (e.g HIV/AIDS, cancer and severe anaemia) judged by&#xD;
             the investigator to be a potential interference in the treatment&#xD;
&#xD;
          -  Subject not expected to follow the investigation procedures&#xD;
&#xD;
          -  Subjects previously included in this investigation&#xD;
&#xD;
          -  Subjects included in other ongoing clinical investigation at present or during the&#xD;
             past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hans Schweiger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida Gulf-toBay Anesthesiology, Tampa Bay Circle</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Florida Gulf-to-bay Anesthesiology</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Plastic Surgical Group, P.C</name>
      <address>
        <city>Garden City</city>
        <state>New York</state>
        <zip>11530</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>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <results_first_submitted>January 22, 2014</results_first_submitted>
  <results_first_submitted_qc>January 22, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 5, 2014</results_first_posted>
  <last_update_submitted>April 1, 2020</last_update_submitted>
  <last_update_submitted_qc>April 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2020</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>Dressing</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: A soft silicone wound contact layer.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </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>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.7" spread="18.7"/>
                  </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="5"/>
                  </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="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Wound Healing</title>
        <description>Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. (&quot;The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.&quot;) Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier.</description>
        <time_frame>14 days and 21 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dressing</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: A soft silicone wound contact layer.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Wound Healing</title>
          <description>Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. (&quot;The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.&quot;) Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline (Visit 1) Pain Will be Measured Before Burn Assessment Visit 2-3, Pain Will be Measured (Pain BEFORE Dressing Removal, DURING Dressing Removal, AFTER Dressing Removal, 30 Min After Removal</title>
        <description>Pain will be measured by using the VAS scale, by placing a vertical mark across the 100 mm long horizontal line, from No pain to the left to Most intense pain imaginable to the right.&#xD;
Baseline (Visit 1) Pain will be measured before burn assessment Visit 2-4, Pain will be measured (Pain BEFORE dressing removal, DURING dressing removal, AFTER dressing removal, 30 min after removal</description>
        <time_frame>After 0/14/21 days treatment</time_frame>
        <population>No data collected</population>
        <group_list>
          <group group_id="O1">
            <title>Pain Measure</title>
          </group>
        </group_list>
        <measure>
          <title>Baseline (Visit 1) Pain Will be Measured Before Burn Assessment Visit 2-3, Pain Will be Measured (Pain BEFORE Dressing Removal, DURING Dressing Removal, AFTER Dressing Removal, 30 Min After Removal</title>
          <description>Pain will be measured by using the VAS scale, by placing a vertical mark across the 100 mm long horizontal line, from No pain to the left to Most intense pain imaginable to the right.&#xD;
Baseline (Visit 1) Pain will be measured before burn assessment Visit 2-4, Pain will be measured (Pain BEFORE dressing removal, DURING dressing removal, AFTER dressing removal, 30 min after removal</description>
          <population>No data collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Dressing</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: A soft silicone wound contact layer.</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="0" subjects_at_risk="10"/>
              </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="10"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Joan Wilson</name_or_title>
      <organization>Mölnlycke Health Care</organization>
      <phone>+1 706-650-1012</phone>
      <email>joan.wilson@molnlycke.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/NCT01734317
org study id: MxT Ag 02
nct id: NCT01734317
lead sponsor: 
has dmc: No
Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or
      the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or
      superficial deep-partial-thickness. The subject will be assessed once a week for a maximum of
      3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex Transfer
      Ag will be used as wound contact layer and gauze rolls and compression as second dressing.
Approximately 10 subjects from one site will be evaluated provided they fulfill the inclusion
      criteria and none of the exclusion criteria and gives a signed and dated consent.

      Subjects may have sustained a burn injury covering 1-25% of the Total Body Surface Area
      (TBSA)and assessed as superficial partial-thickness or superficial deep-partial thickness in
      dept. Each subject will be followed one time per week for a maximum of 3 weeks or until the
      burn is healed if that occurs earlier. Healing is defined as ≥95% epithelialisation. Percent
      (%) healed epithelialization will be measured by photo analysing using the PictZar program.
      Dressing changes will be performed at each visit and in between if deemed necessary by the
      investigator.Gauze rolls and compression will be used as secondary dressing.All dressing
      changes will be registered in a log. Pain before, during and after removal will be assessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Wound Healing
time frame: 14 days and 21 days
description: Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. ("The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.") Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier.
measure: Baseline (Visit 1) Pain Will be Measured Before Burn Assessment Visit 2-3, Pain Will be Measured (Pain BEFORE Dressing Removal, DURING Dressing Removal, AFTER Dressing Removal, 30 Min After Removal
time frame: After 0/14/21 days treatment
description: Pain will be measured by using the VAS scale, by placing a vertical mark across the 100 mm long horizontal line, from No pain to the left to Most intense pain imaginable to the right.
Baseline (Visit 1) Pain will be measured before burn assessment Visit 2-4, Pain will be measured (Pain BEFORE dressing removal, DURING dressing removal, AFTER dressing removal, 30 min after removal
arm group label: Dressing
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: A soft silicone wound contact layer.
arm group label: Dressing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hans Schweiger, MD
role: Principal Investigator
affiliation: Florida Gulf-toBay Anesthesiology, Tampa Bay Circle
facility: 
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 