<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/NCT02994654</url>
  </required_header>
  <id_info>
    <org_study_id>CTP001-7</org_study_id>
    <nct_id>NCT02994654</nct_id>
  </id_info>
  <brief_title>CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries</brief_title>
  <official_title>CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Avita Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Avita Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall purpose of this is study to provide continued access to the ReCell device&#xD;
      following completion of protocol CTP001-6, and allow for collection of supplementary clinical&#xD;
      outcome data for the ReCell device when used as an adjunct to meshed grafts in subjects with&#xD;
      acute thermal burn injuries who require skin grafting for closure of burn injuries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)</measure>
    <time_frame>Prior to or at 8 weeks</time_frame>
    <description>Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative Reduction in Donor Skin Area Requirement</measure>
    <time_frame>Prior to or at 8 weeks</time_frame>
    <description>For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Burns</condition>
  <arm_group>
    <arm_group_label>ReCell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Control, which is the Investigator's pre-determined graft plan will be randomly allocated to either Area A or Area B</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ReCell</intervention_name>
    <description>The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.&#xD;
The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>ReCell</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject requires skin grafting as a result of an acute thermal burn injury (i.e.&#xD;
             injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or&#xD;
             water).&#xD;
&#xD;
          2. The area of total burn injury is 5-50% TBSA inclusive.&#xD;
&#xD;
          3. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous),&#xD;
             excluding hand/face and joints.&#xD;
&#xD;
          4. The subject is at least 5 years of age.&#xD;
&#xD;
          5. The subject (or family, for those under 18 years of age) is willing and able to&#xD;
             complete all follow-up evaluations required by the study protocol.&#xD;
&#xD;
          6. The subject is to abstain from any other treatment of the wound(s) for the duration of&#xD;
             the study unless medically necessary.&#xD;
&#xD;
          7. The subject agrees to abstain from enrollment in any other interventional clinical&#xD;
             trial for the duration of the study.&#xD;
&#xD;
          8. The subject and/or guardian are able to read and understand instructions and give&#xD;
             informed, voluntary, written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive&#xD;
             substances.&#xD;
&#xD;
          2. The subject is unable to follow the protocol.&#xD;
&#xD;
          3. The subject has other concurrent conditions that in the opinion of the investigator&#xD;
             may compromise patient safety or study objectives.&#xD;
&#xD;
          4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for&#xD;
             irrigation (Hartmann's) solution.&#xD;
&#xD;
          5. Life expectancy is less than 1year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arizona Burn Center at Maricopa Integrated Health Systems</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85008</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>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest 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 Tennessee Health Science Center</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103-3409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.S.Army Institute of Surgical Research</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234-7767</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <results_first_submitted>February 26, 2021</results_first_submitted>
  <results_first_submitted_qc>April 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 4, 2021</results_first_posted>
  <last_update_submitted>April 9, 2021</last_update_submitted>
  <last_update_submitted_qc>April 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 25, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT02994654/Prot_ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT02994654/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental: All Participants (Within Patient Control)</title>
          <description>Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control. Each subject's study treatment area (burn injury) was divided into Area A and Area B before the areas (A and B) were randomly assigned to receive CONTROL (grafting consistent with the pre-identified graft plan) or RECELL (RECELL-generated cell suspension applied over a graft more widely meshed than identified in the pre-specified graft plan).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Experimental: All Participants (Within Patient Control)</title>
          <description>All subjects receive both ReCell treatment and autograft (Area A and Area B). Each subject serves as their own control. Wound regions were randomly assigned to receive an autograft consistent with the investigator's pre-identified graft plan (Control) or to receive application of the ReCell-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (ReCell-treated).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </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="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.6" spread="12.93"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)</title>
        <description>Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.</description>
        <time_frame>Prior to or at 8 weeks</time_frame>
        <population>Per Protocol</population>
        <group_list>
          <group group_id="O1">
            <title>ReCell</title>
            <description>All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B&#xD;
ReCell: The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.&#xD;
The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Control, which is the Investigator's pre-determined graft plan will be randomly allocated to either Area A or Area B&#xD;
ReCell: The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.&#xD;
The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)</title>
          <description>Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.</description>
          <population>Per Protocol</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="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Relative Reduction in Donor Skin Area Requirement</title>
        <description>For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.</description>
        <time_frame>Prior to or at 8 weeks</time_frame>
        <population>Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>ReCell</title>
            <description>All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B&#xD;
ReCell: The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.&#xD;
The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Control, which is the Investigator's pre-determined graft plan will be randomly allocated to either Area A or Area B&#xD;
ReCell: The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.&#xD;
The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Reduction in Donor Skin Area Requirement</title>
          <description>For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.</description>
          <population>Intent-to-Treat Population</population>
          <units>cm2</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1139" spread="2.2893"/>
                    <measurement group_id="O2" value="1.6523" spread="1.7578"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>52 Weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>All Participants</title>
          <description>All subjects receive both ReCell treatment and autograft (Area A and Area B). Each subject serves as their own control. Wound regions were randomly assigned to receive an autograft consistent with the investigator's pre-identified graft plan (Control) or to receive application of the ReCell-generated cell suspension over an autograft more widely meshed than identified in the investigator's pre-specified graft plan (ReCell-treated).</description>
        </group>
      </group_list>
      <serious_events>
        <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="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Failed Skin Graft</sub_title>
                <description>RECELL</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Delayed Wound Healing</sub_title>
                <description>RECELL</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Failed Skin Graft</sub_title>
                <description>NON-STUDY AREA</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Respiratory Distress</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="7" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Delayed Wound Healing</sub_title>
                <description>RECELL</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Non-healing Burn Wound</sub_title>
                <description>RECELL</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Failed Skin Graft</sub_title>
                <description>RECELL</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Graft Loss Left Abdomen</sub_title>
                <description>RECELL</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Graft Loss Right Abdomen</sub_title>
                <description>CONTROL</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Failed Skin Graft</sub_title>
                <description>NON-STUDY AREA</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Right Thigh Graft Loss</sub_title>
                <description>NON-STUDY AREA</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Graft Loss Left Upper Arm</sub_title>
                <description>NON-STUDY AREA</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hypertrophic Scar</sub_title>
                <description>NON-STUDY AREA</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Distress</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Severe Intermittent Nerve Pain</sub_title>
                <description>CONTROL</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </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 NOT 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>VP Clinical Research</name_or_title>
      <organization>AVITA Medical</organization>
      <phone>661-367-9170</phone>
      <email>USClinicalTrials@avitamedical.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/NCT02994654
org study id: CTP001-7
nct id: NCT02994654
lead sponsor: 
has dmc: No
The overall purpose of this is study to provide continued access to the ReCell device
      following completion of protocol CTP001-6, and allow for collection of supplementary clinical
      outcome data for the ReCell device when used as an adjunct to meshed grafts in subjects with
      acute thermal burn injuries who require skin grafting for closure of burn injuries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
time frame: Prior to or at 8 weeks
description: Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.
measure: Relative Reduction in Donor Skin Area Requirement
time frame: Prior to or at 8 weeks
description: For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.
arm group label: ReCell
arm group type: Experimental
description: All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
arm group label: Control
arm group type: Experimental
description: All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Control, which is the Investigator's pre-determined graft plan will be randomly allocated to either Area A or Area B
intervention type: Device
intervention name: ReCell
description: The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.
The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded.
arm group label: Control
arm group label: ReCell
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Burns
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 