<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/NCT02992249</url>
  </required_header>
  <id_info>
    <org_study_id>CTP004</org_study_id>
    <nct_id>NCT02992249</nct_id>
  </id_info>
  <brief_title>Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases</brief_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>
      This is a prospective uncontrolled observational study to evaluate clinical outcomes&#xD;
      following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for&#xD;
      closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting&#xD;
      for closure, and associated skin graft donor sites, in patients who lack adequate available&#xD;
      skin to harvest for conventional grafting. Treatment with the ReCell device may be performed&#xD;
      as part of a single operative procedure, or multiple staged procedures as deemed clinically&#xD;
      necessary. Adverse events associated with the use of the ReCell device/cell suspension will&#xD;
      be documented. Subjects will be followed for 1 year following ReCell treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">May 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Wound Healing</measure>
    <time_frame>Wound healing assessed at all study visits</time_frame>
    <description>&gt; 95% epithelialization with a contiguous layer of viable epithelium</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Burns</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This is a prospective uncontrolled observational study to evaluate clinical outcomes&#xD;
        following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for&#xD;
        closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting&#xD;
        for closure, and associated skin graft donor sites, in patients who lack adequate available&#xD;
        skin to harvest for conventional grafting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient requires treatment of a life-threatening wound requiring grafting.&#xD;
&#xD;
          -  Patient has inadequate available skin to harvest for conventional skin grafting.&#xD;
&#xD;
          -  The treating investigator has determined 1) that there is no suitable alternative&#xD;
             therapy that would be adequate to meet the patient's medical need; and 2) the risk&#xD;
             associated with use of the ReCell device is no greater than the probable risk from the&#xD;
             disease or condition.&#xD;
&#xD;
          -  In the treating investigator's opinion and with consideration of the severity of the&#xD;
             patient's health status, the patient has the potential to realize benefits from the&#xD;
             application of the ReCell device.&#xD;
&#xD;
          -  Patient is hemodynamically stable.&#xD;
&#xD;
          -  The patient (or legal representative) is able to read and understand instructions and&#xD;
             give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has active infection at the proposed ReCell treatment site.&#xD;
&#xD;
          -  The patient is unable to follow the protocol.&#xD;
&#xD;
          -  The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for&#xD;
             Irrigation (Hartmann's) solution.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of South Alabama Department of Surgery</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36688</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>University of California San Diego Regional Burn Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103-8896</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>Grady Memorial Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joseph M Still Research Foundation</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Richard M. Fairbanks Burn Center at Eskenazi Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baton Rouge General Regional Burn 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>Maine Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center Bethesda</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shriner's Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MS Burn &amp; Reconstruction Center, Merit Health Central</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri Health Care</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy General Burn Center - Springfield</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Christopher's Hospital for Children</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19134</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>
    <facility>
      <name>University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02992249
org study id: CTP004
nct id: NCT02992249
lead sponsor: 
has dmc: No
This is a prospective uncontrolled observational study to evaluate clinical outcomes
      following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for
      closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting
      for closure, and associated skin graft donor sites, in patients who lack adequate available
      skin to harvest for conventional grafting. Treatment with the ReCell device may be performed
      as part of a single operative procedure, or multiple staged procedures as deemed clinically
      necessary. Adverse events associated with the use of the ReCell device/cell suspension will
      be documented. Subjects will be followed for 1 year following ReCell treatment.
observational model: Case-Only
time perspective: Prospective
measure: Wound Healing
time frame: Wound healing assessed at all study visits
description: > 95% epithelialization with a contiguous layer of viable epithelium
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
sharing ipd: No