<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/NCT03005106</url>
  </required_header>
  <id_info>
    <org_study_id>STRATA2016</org_study_id>
    <nct_id>NCT03005106</nct_id>
  </id_info>
  <brief_title>StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements</brief_title>
  <official_title>A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated</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 70 participants will be enrolled. They will have complex skin defects because of burns&#xD;
      caused by heat.&#xD;
&#xD;
      The burns will:&#xD;
&#xD;
        -  be on 3-49% of the participant's total body surface area (TBSA)&#xD;
&#xD;
        -  require surgery for skin replacement&#xD;
&#xD;
        -  include intact dermal elements&#xD;
&#xD;
      The burns are called deep, partial-thickness thermal burns because the skin was damaged by&#xD;
      heat but still has some dermis that was not damaged.&#xD;
&#xD;
      The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer&#xD;
      of the skin that provides strength and flexibility to the skin.&#xD;
&#xD;
      All patients will receive both treatments, but on different areas of their burns. Their&#xD;
      wounds will not be compared to other patients. One treatment area on their own body will be&#xD;
      compared to the other one.&#xD;
&#xD;
      This will help to find out if StrataGraft is safe and effective for deep partial thickness&#xD;
      burns. It will also see if StrataGraft might help healing enough to use it instead of the&#xD;
      patient's own healthy skin to repair the damage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2017</start_date>
  <completion_date type="Actual">March 27, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</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 Treatment Sites Requiring Autografting by Month 3</measure>
    <time_frame>3 Months</time_frame>
    <description>Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)</measure>
    <time_frame>Month 3</time_frame>
    <description>Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain at the Designated Donor Sites by Day 14</measure>
    <time_frame>Day 3, Day 7 and Day 14, average of the 3 days reported</time_frame>
    <description>Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Scar Assessment (POSAS) Score by Observer at Month 3</measure>
    <time_frame>at Month 3</time_frame>
    <description>Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Burn, Thermal</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 burns. 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 burn wound.</description>
    <arm_group_label>StrataGraft Skin Tissue</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Subject-specific criteria:&#xD;
&#xD;
          1. Men and women aged ≥ 18 years&#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. Clinical expectation that the study donor site will heal without grafting&#xD;
&#xD;
          5. Complex skin defects of 3-49% TBSA&#xD;
&#xD;
               -  Total burn may consist of more than one area&#xD;
&#xD;
             Treatment site-specific criteria:&#xD;
&#xD;
          6. Thermal burn(s) with intact dermal elements for which excision and autografting are&#xD;
             clinically indicated&#xD;
&#xD;
          7. Total of both study treatment areas can be up to 2000 cm2&#xD;
&#xD;
          8. First excision and grafting of study treatment sites&#xD;
&#xD;
          9. Thermal burn(s) on the torso, arms, or legs&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Subject-specific criteria:&#xD;
&#xD;
          1. Pregnant women&#xD;
&#xD;
          2. Prisoners&#xD;
&#xD;
          3. Subjects receiving systemic immunosuppressive therapy&#xD;
&#xD;
          4. Subjects with a known history of malignancy&#xD;
&#xD;
          5. Preadmission insulin-dependent diabetic subjects&#xD;
&#xD;
          6. Subjects with concurrent conditions that in the opinion of the investigator may&#xD;
             compromise subject safety or study objectives&#xD;
&#xD;
          7. Expected survival of less than three months&#xD;
&#xD;
          8. Participation in the treatment group of an interventional study within 90 days prior&#xD;
             to enrollment&#xD;
&#xD;
             Treatment site-specific criteria:&#xD;
&#xD;
          9. Full-thickness burns&#xD;
&#xD;
         10. Chronic wounds&#xD;
&#xD;
         11. The face, head, neck, hands, feet, buttocks, and area over joints&#xD;
&#xD;
         12. Treatment sites immediately adjacent to unexcised eschar&#xD;
&#xD;
         13. Clinical or laboratory determination of infection at the anticipated treatment sites&#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>Clinical Team Leader</last_name>
    <role>Study Director</role>
    <affiliation>Stratatech, a Mallinckrodt Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of South Alabama Medical Center</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Burn Center at Maricopa Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universtiy of California - Irvine Health Regional Burn Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Shands Burn Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital - Regional Burn Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baton Rouge Medical Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</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>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Medical Center Firefighters Burn Center</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</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>June 18, 2021</results_first_submitted>
  <results_first_submitted_qc>June 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 12, 2021</results_first_posted>
  <disposition_first_submitted>March 17, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>March 19, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 23, 2020</disposition_first_posted>
  <last_update_submitted>July 12, 2021</last_update_submitted>
  <last_update_submitted_qc>July 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Trauma-related wound</keyword>
  <keyword>Deep partial thickness</keyword>
  <keyword>Skin wound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</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 (NCT03005106) 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>May 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03005106/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Participants</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 burns. 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 burn 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="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Month 3 Visit</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Month 12 Visit</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants</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 burns. 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 burn wound.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="71"/>
          </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="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="45" lower_limit="19" upper_limit="79"/>
                  </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="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Area of Treatment Sites Requiring Autografting by Month 3</title>
        <description>Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).</description>
        <time_frame>3 Months</time_frame>
        <population>Modified Intent to Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</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 burns. 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 burn wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Area of Treatment Sites Requiring Autografting by Month 3</title>
          <description>Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).</description>
          <population>Modified Intent to Treat Population</population>
          <units>percentage of treatment sites</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>StrataGraft (Treatment) Sites</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread="21.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Autograft (Control) Sites</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.10" spread="13.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Difference between treatment and control sites</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Difference is (percent area of Autograft treatment site requiring autografting by Month 3) - (percent area of StrataGraft treatment site requiring autografting by Month 3).</p_value_desc>
            <method>one-sided Wilcoxin Signed RankTtest</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>97.77</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)</title>
        <description>Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.</description>
        <time_frame>Month 3</time_frame>
        <population>Modified Intent to Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</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 burns. 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 burn wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)</title>
          <description>Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.</description>
          <population>Modified Intent to Treat 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="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Percentage of participants</param_type>
            <param_value>83.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>74.4</ci_lower_limit>
            <ci_upper_limit>91.8</ci_upper_limit>
            <estimate_desc>95% confidence interval is derived using the normal approximation to the binomial distribution</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain at the Designated Donor Sites by Day 14</title>
        <description>Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics.</description>
        <time_frame>Day 3, Day 7 and Day 14, average of the 3 days reported</time_frame>
        <population>Modified Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</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 burns. 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 burn wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain at the Designated Donor Sites by Day 14</title>
          <description>Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics.</description>
          <population>Modified Intent to Treat</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>StrataGraft (Treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Autograft (Control)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.55" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Difference is Autograft - StrataGraft</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <method>1-sided, paired t-test</method>
            <method_desc>p-value from 1-sided, paired t-test on the mean difference(Autograft - StrataGraft)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.40</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Scar Assessment (POSAS) Score by Observer at Month 3</title>
        <description>Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60.</description>
        <time_frame>at Month 3</time_frame>
        <population>Maximum number of participants with data at Month 3 in the modified Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</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 burns. 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 burn wound.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Scar Assessment (POSAS) Score by Observer at Month 3</title>
          <description>Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60.</description>
          <population>Maximum number of participants with data at Month 3 in the modified Intent to Treat population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>StrataGraft (Treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Autograft (Control)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" spread="7.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Difference is Autograft - StrataGraft</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Missing total score data were imputed using a multiple imputation analysis assuming a monotone missing data pattern. A linear regression model with ethnicity, race and age as predictive variables was used in the imputation.</p_value_desc>
            <method>1-sided, paired t-test</method>
            <method_desc>p-value from 1-sided, paired t-test on the difference (Autograft - StrataGraft)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>10.0</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through the 12-month follow-up</time_frame>
      <desc>Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.</desc>
      <group_list>
        <group group_id="E1">
          <title>All Participants</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 burns. 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 burn 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="2" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Concomitant disease progression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Enterobacter bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Pseudomonal bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="49" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Donor site complication</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Excessive granulation tissue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Hypertrophic scar</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="29" subjects_affected="25" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="71"/>
              </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>
    <point_of_contact>
      <name_or_title>Medical Information Call Center</name_or_title>
      <organization>Mallinckrodt</organization>
      <phone>800-844-2830</phone>
      <email>MedInfo@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/NCT03005106
org study id: STRATA2016
nct id: NCT03005106
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
About 70 participants will be enrolled. They will have complex skin defects because of burns
      caused by heat.

      The burns will:

        -  be on 3-49% of the participant's total body surface area (TBSA)

        -  require surgery for skin replacement

        -  include intact dermal elements

      The burns are called deep, partial-thickness thermal burns because the skin was damaged by
      heat but still has some dermis that was not damaged.

      The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer
      of the skin that provides strength and flexibility to the skin.

      All patients will receive both treatments, but on different areas of their burns. Their
      wounds will not be compared to other patients. One treatment area on their own body will be
      compared to the other one.

      This will help to find out if StrataGraft is safe and effective for deep partial thickness
      burns. It will also see if StrataGraft might help healing enough to use it instead of the
      patient's own healthy skin to repair the damage.
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 Treatment Sites Requiring Autografting by Month 3
time frame: 3 Months
description: Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
measure: Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)
time frame: Month 3
description: Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.
measure: Pain at the Designated Donor Sites by Day 14
time frame: Day 3, Day 7 and Day 14, average of the 3 days reported
description: Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics.
measure: Total Scar Assessment (POSAS) Score by Observer at Month 3
time frame: at Month 3
description: Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60.
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 burns. 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 burn wound.
arm group label: StrataGraft Skin Tissue
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Team Leader
role: Study Director
affiliation: Stratatech, a Mallinckrodt Company
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Burns
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 (NCT03005106) 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: 
point of contact: 