<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/NCT03005054</url>
  </required_header>
  <id_info>
    <org_study_id>STRATA2014</org_study_id>
    <secondary_id>W81XWH-16-C-0202</secondary_id>
    <nct_id>NCT03005054</nct_id>
  </id_info>
  <brief_title>StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects</brief_title>
  <official_title>Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stratatech, a Mallinckrodt Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mallinckrodt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      About 20 participants will be enrolled in this trial if they have had an accident that&#xD;
      damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their&#xD;
      body.&#xD;
&#xD;
      This condition is called full-thickness complex skin defects resulting from acute traumatic&#xD;
      skin loss.&#xD;
&#xD;
      Participants will be treated with StrataGraft skin tissue to evaluate it's safety and&#xD;
      effectiveness for use in treating full-thickness complex skin defects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this range-finding study was to assess the safety, tolerability, and&#xD;
      efficacy of single or repeated application of StrataGraft skin tissue in full-thickness&#xD;
      complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving&#xD;
      injuries) requiring surgical excision and autografting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Protracted enrollment and limited wound closure in the first three subjects&#xD;
  </why_stopped>
  <start_date type="Actual">April 24, 2017</start_date>
  <completion_date type="Actual">March 26, 2019</completion_date>
  <primary_completion_date type="Actual">March 26, 2019</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>See detailed description</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months</measure>
    <time_frame>3 months</time_frame>
    <description>The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months</measure>
    <time_frame>3 months</time_frame>
    <description>Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months</measure>
    <time_frame>within 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months</measure>
    <time_frame>within 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Wound Closure at 3, 6, and 12 Months</measure>
    <time_frame>within 3, 6, and 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmesis of Treatment Sites at 3, 6, and 12 Months</measure>
    <time_frame>within 3, 6, and 12 Months</time_frame>
    <description>Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmesis of Donor Sites at 3, 6, and 12 Months</measure>
    <time_frame>within 3, 6, and 12 Months</time_frame>
    <description>Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28</measure>
    <time_frame>at days 3, 7, 14, 21, and 28</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Trauma-related Wound</condition>
  <condition>Burns</condition>
  <condition>Skin Wound</condition>
  <arm_group>
    <arm_group_label>StrataGraft skin tissue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>StrataGraft Skin Tissue</intervention_name>
    <description>StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).</description>
    <arm_group_label>StrataGraft skin tissue</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autograft</intervention_name>
    <description>The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
    <arm_group_label>StrataGraft skin tissue</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women aged 18-65 years, inclusive&#xD;
&#xD;
          2. Written informed consent&#xD;
&#xD;
          3. Sufficient healthy skin identified and reserved as a donor site in the event that the&#xD;
             StrataGraft treatment site requires autografting&#xD;
&#xD;
          4. Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision&#xD;
             and autografting&#xD;
&#xD;
               -  Total skin defect may consist of more than one wound area&#xD;
&#xD;
          5. Full-thickness complex skin defects requiring excision and autografting&#xD;
&#xD;
          6. Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400&#xD;
             cm2 in cohort 2&#xD;
&#xD;
          7. For thermal burns only, first excision and grafting of treatment sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women and prisoners&#xD;
&#xD;
          2. Subjects receiving systemic immunosuppressive therapy&#xD;
&#xD;
          3. Subjects with a known history of malignancy&#xD;
&#xD;
          4. Preadmission insulin-dependent diabetic subjects&#xD;
&#xD;
          5. Subjects with concurrent conditions that in the opinion of the investigator may&#xD;
             compromise subject safety or study objectives&#xD;
&#xD;
          6. Expected survival of less than three months&#xD;
&#xD;
          7. Participation in the treatment group of an interventional study within the 90 days&#xD;
             prior to enrollment&#xD;
&#xD;
          8. Chronic wounds&#xD;
&#xD;
          9. The face, head, neck, hands, feet, buttocks, perineum, and area over joints&#xD;
&#xD;
         10. Treatment sites with exposed tendon or bony prominences&#xD;
&#xD;
         11. Chemical and electrical burns&#xD;
&#xD;
         12. Treatment sites adjacent to unexcised eschar&#xD;
&#xD;
         13. Clinical suspicion of infection at the anticipated treatment sites&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Mallinckrodt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Burn Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.S. Army Institute of Surgical Research Adult Burn Center</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234-6315</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Hospital</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <results_first_submitted>March 10, 2021</results_first_submitted>
  <results_first_submitted_qc>July 13, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 3, 2021</results_first_posted>
  <disposition_first_submitted>March 17, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>July 13, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 3, 2021</disposition_first_posted>
  <last_update_submitted>July 13, 2021</last_update_submitted>
  <last_update_submitted_qc>July 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Full-thickness</keyword>
  <keyword>Acute trauma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03005054) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT03005054/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>StrataGraft Skin Tissue</title>
          <description>StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).&#xD;
Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </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>
      <population>All participants</population>
      <group_list>
        <group group_id="B1">
          <title>StrataGraft Skin Tissue</title>
          <description>StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).&#xD;
Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" lower_limit="21" upper_limit="56"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months</title>
        <description>The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.</description>
        <time_frame>3 months</time_frame>
        <population>All participants</population>
        <group_list>
          <group group_id="O1">
            <title>StrataGraft Skin Tissue</title>
            <description>StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).&#xD;
Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months</title>
          <description>The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.</description>
          <population>All participants</population>
          <units>percentage of treatment site</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participant 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months</title>
        <description>Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage</description>
        <time_frame>3 months</time_frame>
        <population>All participants</population>
        <group_list>
          <group group_id="O1">
            <title>StrataGraft Skin Tissue</title>
            <description>StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).&#xD;
Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months</title>
          <description>Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage</description>
          <population>All participants</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months</title>
        <time_frame>within 3 months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>StrataGraft Skin Tissue</title>
            <description>StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).&#xD;
Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months</title>
          <population>Data were not 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>
        <type>Secondary</type>
        <title>Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months</title>
        <time_frame>within 3, 6 and 12 months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>StrataGraft Skin Tissue</title>
            <description>StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).&#xD;
Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months</title>
          <population>Data were not 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>
        <type>Secondary</type>
        <title>Percent Wound Closure at 3, 6, and 12 Months</title>
        <time_frame>within 3, 6, and 12 Months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>StrataGraft Skin Tissue</title>
            <description>StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).&#xD;
Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Wound Closure at 3, 6, and 12 Months</title>
          <population>Data were not 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>
        <type>Secondary</type>
        <title>Cosmesis of Treatment Sites at 3, 6, and 12 Months</title>
        <description>Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance</description>
        <time_frame>within 3, 6, and 12 Months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>StrataGraft Skin Tissue</title>
            <description>StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).&#xD;
Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Cosmesis of Treatment Sites at 3, 6, and 12 Months</title>
          <description>Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance</description>
          <population>Data were not 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>
        <type>Secondary</type>
        <title>Cosmesis of Donor Sites at 3, 6, and 12 Months</title>
        <description>Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance</description>
        <time_frame>within 3, 6, and 12 Months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>StrataGraft Skin Tissue</title>
            <description>StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).&#xD;
Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Cosmesis of Donor Sites at 3, 6, and 12 Months</title>
          <description>Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance</description>
          <population>Data were not 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>
        <type>Secondary</type>
        <title>Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28</title>
        <time_frame>at days 3, 7, 14, 21, and 28</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>StrataGraft Skin Tissue</title>
            <description>StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).&#xD;
Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28</title>
          <population>Data were not 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>
      <time_frame>3 months</time_frame>
      <desc>Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.</desc>
      <group_list>
        <group group_id="E1">
          <title>StrataGraft Skin Tissue</title>
          <description>StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).&#xD;
Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Graft complication</sub_title>
                <description>Unrelated to treatment</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>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="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Graft complication</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Excessive granulation tissue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to protracted enrollment and limited wound closure in the first three subjects, the Sponsor decided to end further enrollment and the study was terminated with only 3 subjects enrolled into Cohort 1. No participants were enrolled into Cohort 2. Therefore, posted results include primary outcome measures for the 3 subjects enrolled, but no data for the secondary outcome measures.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Medical Information Call Center</name_or_title>
      <organization>Mallinckrodt</organization>
      <phone>800-844-2830 ext 5</phone>
      <email>clinicaltrials@mnk.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/NCT03005054
org study id: STRATA2014
secondary id: W81XWH-16-C-0202
nct id: NCT03005054
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
About 20 participants will be enrolled in this trial if they have had an accident that
      damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their
      body.

      This condition is called full-thickness complex skin defects resulting from acute traumatic
      skin loss.

      Participants will be treated with StrataGraft skin tissue to evaluate it's safety and
      effectiveness for use in treating full-thickness complex skin defects.
The objective of this range-finding study was to assess the safety, tolerability, and
      efficacy of single or repeated application of StrataGraft skin tissue in full-thickness
      complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving
      injuries) requiring surgical excision and autografting.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: See detailed description
primary purpose: Treatment
masking: None (Open Label)
measure: Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months
time frame: 3 months
description: The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.
measure: Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months
time frame: 3 months
description: Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage
measure: Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months
time frame: within 3 months
measure: Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months
time frame: within 3, 6 and 12 months
measure: Percent Wound Closure at 3, 6, and 12 Months
time frame: within 3, 6, and 12 Months
measure: Cosmesis of Treatment Sites at 3, 6, and 12 Months
time frame: within 3, 6, and 12 Months
description: Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
measure: Cosmesis of Donor Sites at 3, 6, and 12 Months
time frame: within 3, 6, and 12 Months
description: Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
measure: Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28
time frame: at days 3, 7, 14, 21, and 28
arm group label: StrataGraft skin tissue
arm group type: Experimental
intervention type: Biological
intervention name: StrataGraft Skin Tissue
description: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
arm group label: StrataGraft skin tissue
intervention type: Procedure
intervention name: Autograft
description: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
arm group label: StrataGraft skin tissue
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Mallinckrodt
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No
ipd description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03005054) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to protracted enrollment and limited wound closure in the first three subjects, the Sponsor decided to end further enrollment and the study was terminated with only 3 subjects enrolled into Cohort 1. No participants were enrolled into Cohort 2. Therefore, posted results include primary outcome measures for the 3 subjects enrolled, but no data for the secondary outcome measures.
point of contact: 