<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/NCT02980601</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00031531</org_study_id>
    <secondary_id>CCCWFU 99915A</secondary_id>
    <nct_id>NCT02980601</nct_id>
  </id_info>
  <brief_title>The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect</brief_title>
  <official_title>The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to compare the forearm free flap of patients with a&#xD;
      traditional split thickness skin graft and those repaired with Integra (a skin substitute&#xD;
      that helps to provide wound closure) and a split thickness skin graft. The study team will be&#xD;
      looking at the subject's satisfaction with how the skin graft site looks and how well the&#xD;
      skin graft site is functioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The radial forearm fasciocutaneous free flap (hereafter referred to as RFFF) was described&#xD;
      more than 30 years ago as a fasciocutaneous flap for microsurgical transfer. It was soon&#xD;
      after established as a safe and reliable flap for transfer of fascia and cutaneous tissue.&#xD;
      Currently, it is used to repair any defect in which a relatively thin island of skin is&#xD;
      needed with a fascial strength layer . While the flap itself is very reliable, it leaves a&#xD;
      donor site that can be very unsightly and has multiple known complications including loss of&#xD;
      pronation, pain, paresthesias, cold intolerance, and skin graft necrosis. The donor site is&#xD;
      typically covered with a split thickness skin graft (hereafter referred to as STSG). In an&#xD;
      effort to minimize these complications, several groups have described a technique of placing&#xD;
      Integra© dermal substitute (hereafter referred to as Integra) underneath the STSG to provide&#xD;
      a thicker support and decrease overall morbidity associated with the defect. These studies&#xD;
      have shown success in decreasing overall morbidity including increasing range of motion and&#xD;
      improving aesthetic quality of the donor site. However, the largest study to date has&#xD;
      included only 29 subjects. Furthermore, these studies do not provide a comparative cohort of&#xD;
      subjects repaired with a classic STSG to show effectiveness of this technique when compared&#xD;
      to a classic repair. Our goal is to perform a prospective study comparing subjects repaired&#xD;
      with a classic STSG and those repaired with one step Integra and STSG applied at the same&#xD;
      time. These subjects will be evaluated for overall donor site aesthetic quality and&#xD;
      functional outcome as described below.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">August 6, 2018</completion_date>
  <primary_completion_date type="Actual">August 18, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Skin Graft Necrosis.</measure>
    <time_frame>1 year</time_frame>
    <description>Number of participants with skin graft necrosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vancouver Scar Scale</measure>
    <time_frame>1 Year</time_frame>
    <description>The Vancouver Scar Scale will measure donor site aesethetic quality and it encompasses 4 separate outcomes to be objectively assessed. Each has been separately reported in the literature for each group in different papers as previously mentioned. We will compare the final score as well as scores within each outcome.On a scale of 1-13; with higher score denoting worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vancouver Scar Scale - Pigmentation</measure>
    <time_frame>1 year</time_frame>
    <description>Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vancouver Scar Scale - Vascularity</measure>
    <time_frame>1 year</time_frame>
    <description>Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vancouver Scar Scale - Pliability</measure>
    <time_frame>1 year</time_frame>
    <description>Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vancouver Scar Scale - Height</measure>
    <time_frame>1 year</time_frame>
    <description>Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength -Lateral Pinch</measure>
    <time_frame>Pre-op</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength -Lateral Pinch</measure>
    <time_frame>3 month</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength -Lateral Pinch</measure>
    <time_frame>6 months</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength -Lateral Pinch</measure>
    <time_frame>1 year</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength - Grip</measure>
    <time_frame>pre-op</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength - Grip</measure>
    <time_frame>3 month</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength - Grip</measure>
    <time_frame>6 month</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength - Grip</measure>
    <time_frame>1 year</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength- Pincer</measure>
    <time_frame>pre-op</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength- Pincer</measure>
    <time_frame>3 month</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength- Pincer</measure>
    <time_frame>6 month</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Strength- Pincer</measure>
    <time_frame>1 year</time_frame>
    <description>Functional outcomes will be measured by using strength dynamometers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wrist Range of Motion- Flexion</measure>
    <time_frame>pre-op</time_frame>
    <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wrist Range of Motion- Flexion</measure>
    <time_frame>3 month</time_frame>
    <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wrist Range of Motion- Flexion</measure>
    <time_frame>6 month</time_frame>
    <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wrist Range of Motion- Flexion</measure>
    <time_frame>1 year</time_frame>
    <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wrist Range of Motion- Extension</measure>
    <time_frame>pre-op</time_frame>
    <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wrist Range of Motion- Extension</measure>
    <time_frame>3 month</time_frame>
    <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wrist Range of Motion- Extension</measure>
    <time_frame>6 month</time_frame>
    <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wrist Range of Motion- Extension</measure>
    <time_frame>1 year</time_frame>
    <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participant With Tendon Exposure</measure>
    <time_frame>6 month</time_frame>
    <description>Tendon exposure identified clinically.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Tendon Exposure</measure>
    <time_frame>1 year</time_frame>
    <description>Tendon exposure identified clinically.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Scar Assessment- Paresthesia</measure>
    <time_frame>3 month</time_frame>
    <description>Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Scar Assessment- Paresthesia</measure>
    <time_frame>6 month</time_frame>
    <description>Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Scar Assessment- Paresthesia</measure>
    <time_frame>1 year</time_frame>
    <description>Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</measure>
    <time_frame>pre-op</time_frame>
    <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</measure>
    <time_frame>3 month</time_frame>
    <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</measure>
    <time_frame>6 month</time_frame>
    <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</measure>
    <time_frame>1 year</time_frame>
    <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Wound Contracture</measure>
    <time_frame>3 month</time_frame>
    <description>Planimetry Software will be used to measure and determine percentage of wound contracture</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Wound Contracture</measure>
    <time_frame>6 month</time_frame>
    <description>Planimetry Software will be used to measure and determine percentage of wound contracture</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Wound Contracture</measure>
    <time_frame>1 year</time_frame>
    <description>Planimetry Software will be used to measure and determine percentage of wound contracture</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin Pliability</measure>
    <time_frame>1 year</time_frame>
    <description>Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf).</description>
  </primary_outcome>
  <other_outcome>
    <measure>Patient Scar Assessment</measure>
    <time_frame>3 month</time_frame>
    <description>Total score (20-200). Higher scores denote worse outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Scar Assessment</measure>
    <time_frame>6 month</time_frame>
    <description>Total score (20-200). Higher scores denote worse outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Scar Assessment</measure>
    <time_frame>1 year</time_frame>
    <description>Total score (20-200). Higher scores denote worse outcomes.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Integra and a Split Thickness Skin Graft (STSG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Split Thickness Skin Graft (STSG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>reconstruction as dictated by the protocol. They will either receive 1) a 0</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Integra plus STSG</intervention_name>
    <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG</description>
    <arm_group_label>Integra and a Split Thickness Skin Graft (STSG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>STSG</intervention_name>
    <description>0.012mm STSG</description>
    <arm_group_label>Integra and a Split Thickness Skin Graft (STSG)</arm_group_label>
    <arm_group_label>Split Thickness Skin Graft (STSG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects who receive a radial forearm free flaps in the included time period,&#xD;
             including subjects with head and neck cancer, traumatic defects, chronic wounds, or&#xD;
             any other problems that require a radical forearm free flap for reconstruction.&#xD;
&#xD;
          -  Have had a distal, anterograde fasciocutaneous flap&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Ability to understand and the willingness to sign an IRB-approved informed consent&#xD;
             document.&#xD;
&#xD;
          -  Smokers and tobacco users will be included in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have had an osteocutaneous or musculocutaneous flap.&#xD;
&#xD;
          -  Subjects who have a radial forearm flap with a proximal skin flap or subjects that&#xD;
             receive a &quot;reverse&quot; radial forearm flap&#xD;
&#xD;
          -  Pregnant women will be excluded due to the lack of clinical studies evaluating INTEGRA&#xD;
             template in pregnant women.&#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>Joseph Molnar, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>April 26, 2019</results_first_submitted>
  <results_first_submitted_qc>May 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 24, 2019</results_first_posted>
  <last_update_submitted>May 23, 2019</last_update_submitted>
  <last_update_submitted_qc>May 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Traumatic Defect</keyword>
  <keyword>Chronic Wounds</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>November 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT02980601/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Integra and a Split Thickness Skin Graft (STSG)</title>
          <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
        </group>
        <group group_id="P2">
          <title>Split Thickness Skin Graft (STSG)</title>
          <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </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="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Graft loss</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failed to sign consent</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Integra and a Split Thickness Skin Graft (STSG)</title>
          <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
        </group>
        <group group_id="B2">
          <title>Split Thickness Skin Graft (STSG)</title>
          <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </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 group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Skin Graft Necrosis.</title>
        <description>Number of participants with skin graft necrosis.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Skin Graft Necrosis.</title>
          <description>Number of participants with skin graft necrosis.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vancouver Scar Scale</title>
        <description>The Vancouver Scar Scale will measure donor site aesethetic quality and it encompasses 4 separate outcomes to be objectively assessed. Each has been separately reported in the literature for each group in different papers as previously mentioned. We will compare the final score as well as scores within each outcome.On a scale of 1-13; with higher score denoting worse outcome.</description>
        <time_frame>1 Year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Vancouver Scar Scale</title>
          <description>The Vancouver Scar Scale will measure donor site aesethetic quality and it encompasses 4 separate outcomes to be objectively assessed. Each has been separately reported in the literature for each group in different papers as previously mentioned. We will compare the final score as well as scores within each outcome.On a scale of 1-13; with higher score denoting worse outcome.</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vancouver Scar Scale - Pigmentation</title>
        <description>Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome.</description>
        <time_frame>1 year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Vancouver Scar Scale - Pigmentation</title>
          <description>Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome.</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vancouver Scar Scale - Vascularity</title>
        <description>Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.</description>
        <time_frame>1 year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Vancouver Scar Scale - Vascularity</title>
          <description>Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vancouver Scar Scale - Pliability</title>
        <description>Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome.</description>
        <time_frame>1 year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Vancouver Scar Scale - Pliability</title>
          <description>Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome.</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vancouver Scar Scale - Height</title>
        <description>Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.</description>
        <time_frame>1 year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Vancouver Scar Scale - Height</title>
          <description>Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength -Lateral Pinch</title>
        <description>Functional outcomes will be measured by using strength dynamometers.</description>
        <time_frame>Pre-op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength -Lateral Pinch</title>
          <description>Functional outcomes will be measured by using strength dynamometers.</description>
          <units>Lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" spread="4.176123"/>
                    <measurement group_id="O2" value="21.25" spread="2.165064"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength -Lateral Pinch</title>
        <description>Functional outcomes will be measured by using strength dynamometers.</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength -Lateral Pinch</title>
          <description>Functional outcomes will be measured by using strength dynamometers.</description>
          <units>Lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.57142857" spread="4.655477353"/>
                    <measurement group_id="O2" value="16.8" spread="3.059411708"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength -Lateral Pinch</title>
        <description>Functional outcomes will be measured by using strength dynamometers.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength -Lateral Pinch</title>
          <description>Functional outcomes will be measured by using strength dynamometers.</description>
          <units>Lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8" spread="4.833218389"/>
                    <measurement group_id="O2" value="19.33333333" spread="2.494438258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength -Lateral Pinch</title>
        <description>Functional outcomes will be measured by using strength dynamometers.</description>
        <time_frame>1 year</time_frame>
        <population>Data not recorded.</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength -Lateral Pinch</title>
          <description>Functional outcomes will be measured by using strength dynamometers.</description>
          <population>Data not recorded.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength - Grip</title>
        <description>Functional outcomes will be measured by using strength dynamometers.</description>
        <time_frame>pre-op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength - Grip</title>
          <description>Functional outcomes will be measured by using strength dynamometers.</description>
          <units>Lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.4" spread="19.82523644"/>
                    <measurement group_id="O2" value="79.25" spread="16.02146997"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength - Grip</title>
        <description>Functional outcomes will be measured by using strength dynamometers.</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength - Grip</title>
          <description>Functional outcomes will be measured by using strength dynamometers.</description>
          <units>Lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.14285714" spread="22.94358654"/>
                    <measurement group_id="O2" value="66.4" spread="21.81375713"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength - Grip</title>
        <description>Functional outcomes will be measured by using strength dynamometers.</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength - Grip</title>
          <description>Functional outcomes will be measured by using strength dynamometers.</description>
          <units>Lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.4" spread="25.49195952"/>
                    <measurement group_id="O2" value="81.66666667" spread="16.49915823"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength - Grip</title>
        <description>Functional outcomes will be measured by using strength dynamometers.</description>
        <time_frame>1 year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength - Grip</title>
          <description>Functional outcomes will be measured by using strength dynamometers.</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength- Pincer</title>
        <description>Functional outcomes will be measured by using strength dynamometers</description>
        <time_frame>pre-op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength- Pincer</title>
          <description>Functional outcomes will be measured by using strength dynamometers</description>
          <units>Lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4" spread="4.176122604"/>
                    <measurement group_id="O2" value="14.75" spread="3.561951712"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength- Pincer</title>
        <description>Functional outcomes will be measured by using strength dynamometers</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength- Pincer</title>
          <description>Functional outcomes will be measured by using strength dynamometers</description>
          <units>Lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" spread="5.318431563"/>
                    <measurement group_id="O2" value="12.2" spread="5.306599665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength- Pincer</title>
        <description>Functional outcomes will be measured by using strength dynamometers</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength- Pincer</title>
          <description>Functional outcomes will be measured by using strength dynamometers</description>
          <units>Lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4" spread="4.079215611"/>
                    <measurement group_id="O2" value="16" spread="3.265986324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hand Strength- Pincer</title>
        <description>Functional outcomes will be measured by using strength dynamometers</description>
        <time_frame>1 year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Hand Strength- Pincer</title>
          <description>Functional outcomes will be measured by using strength dynamometers</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Wrist Range of Motion- Flexion</title>
        <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
        <time_frame>pre-op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Wrist Range of Motion- Flexion</title>
          <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.83333333" spread="15.44254585"/>
                    <measurement group_id="O2" value="68" spread="16.02146997"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Wrist Range of Motion- Flexion</title>
        <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Wrist Range of Motion- Flexion</title>
          <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.42857143" spread="13.55261854"/>
                    <measurement group_id="O2" value="69" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Wrist Range of Motion- Flexion</title>
        <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Wrist Range of Motion- Flexion</title>
          <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.8" spread="11.66876172"/>
                    <measurement group_id="O2" value="68.333333" spread="6.236095645"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Wrist Range of Motion- Flexion</title>
        <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
        <time_frame>1 year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Wrist Range of Motion- Flexion</title>
          <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Wrist Range of Motion- Extension</title>
        <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
        <time_frame>pre-op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Wrist Range of Motion- Extension</title>
          <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.33333333" spread="9.689627902"/>
                    <measurement group_id="O2" value="49.66666667" spread="7.758060325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Wrist Range of Motion- Extension</title>
        <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Wrist Range of Motion- Extension</title>
          <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" spread="15.58387445"/>
                    <measurement group_id="O2" value="47.5" spread="13.78404875"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Wrist Range of Motion- Extension</title>
        <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Wrist Range of Motion- Extension</title>
          <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.4" spread="21.10544953"/>
                    <measurement group_id="O2" value="70" spread="8.498365856"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Wrist Range of Motion- Extension</title>
        <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
        <time_frame>1 year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Wrist Range of Motion- Extension</title>
          <description>Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participant With Tendon Exposure</title>
        <description>Tendon exposure identified clinically.</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participant With Tendon Exposure</title>
          <description>Tendon exposure identified clinically.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rate of Tendon Exposure</title>
        <description>Tendon exposure identified clinically.</description>
        <time_frame>1 year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Tendon Exposure</title>
          <description>Tendon exposure identified clinically.</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Scar Assessment- Paresthesia</title>
        <description>Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes</description>
        <time_frame>3 month</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Scar Assessment- Paresthesia</title>
          <description>Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Scar Assessment- Paresthesia</title>
        <description>Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes</description>
        <time_frame>6 month</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Scar Assessment- Paresthesia</title>
          <description>Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Scar Assessment- Paresthesia</title>
        <description>Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes</description>
        <time_frame>1 year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Scar Assessment- Paresthesia</title>
          <description>Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</title>
        <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
        <time_frame>pre-op</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</title>
          <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</title>
        <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</title>
          <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
          <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="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.43333333" spread="18.01894065"/>
                    <measurement group_id="O2" value="29.525" spread="23.13118836"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</title>
        <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</title>
          <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
          <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="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.636363636" spread="26.31264662"/>
                    <measurement group_id="O2" value="-9.090909091" spread="16.62356686"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</title>
        <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
        <time_frame>1 year</time_frame>
        <population>data not recorded for all subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)</title>
          <description>Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure</description>
          <population>data not recorded for all subjects</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" spread="11.056672193748"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent of Wound Contracture</title>
        <description>Planimetry Software will be used to measure and determine percentage of wound contracture</description>
        <time_frame>3 month</time_frame>
        <population>data not recorded</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Wound Contracture</title>
          <description>Planimetry Software will be used to measure and determine percentage of wound contracture</description>
          <population>data not recorded</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent of Wound Contracture</title>
        <description>Planimetry Software will be used to measure and determine percentage of wound contracture</description>
        <time_frame>6 month</time_frame>
        <population>data not recorded</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Wound Contracture</title>
          <description>Planimetry Software will be used to measure and determine percentage of wound contracture</description>
          <population>data not recorded</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent of Wound Contracture</title>
        <description>Planimetry Software will be used to measure and determine percentage of wound contracture</description>
        <time_frame>1 year</time_frame>
        <population>data not recorded</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Wound Contracture</title>
          <description>Planimetry Software will be used to measure and determine percentage of wound contracture</description>
          <population>data not recorded</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Skin Pliability</title>
        <description>Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf).</description>
        <time_frame>1 year</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Pliability</title>
          <description>Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf).</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Scar Assessment</title>
        <description>Total score (20-200). Higher scores denote worse outcomes.</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Scar Assessment</title>
          <description>Total score (20-200). Higher scores denote worse outcomes.</description>
          <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="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.14285714" spread="26.03529786"/>
                    <measurement group_id="O2" value="82.25" spread="27.72521416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Scar Assessment</title>
        <description>Total score (20-200). Higher scores denote worse outcomes.</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Scar Assessment</title>
          <description>Total score (20-200). Higher scores denote worse outcomes.</description>
          <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="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.8" spread="78.170071"/>
                    <measurement group_id="O2" value="65.5" spread="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Scar Assessment</title>
        <description>Total score (20-200). Higher scores denote worse outcomes.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integra and a Split Thickness Skin Graft (STSG)</title>
            <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
          </group>
          <group group_id="O2">
            <title>Split Thickness Skin Graft (STSG)</title>
            <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Scar Assessment</title>
          <description>Total score (20-200). Higher scores denote worse outcomes.</description>
          <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="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5" spread="3.5"/>
                    <measurement group_id="O2" value="28" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data was collected during the 1 year of study activities.</time_frame>
      <desc>Definitions do not differ.</desc>
      <group_list>
        <group group_id="E1">
          <title>Integra and a Split Thickness Skin Graft (STSG)</title>
          <description>A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.&#xD;
Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG&#xD;
STSG: 0.012mm STSG</description>
        </group>
        <group group_id="E2">
          <title>Split Thickness Skin Graft (STSG)</title>
          <description>reconstruction as dictated by the protocol. They will either receive 1) a 0&#xD;
STSG: 0.012mm STSG</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="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Subject deceased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Joseph Molnar</name_or_title>
      <organization>Wake Forest Baptist Health</organization>
      <phone>336-716-4171</phone>
      <email>jmolnar@wakehealth.edu</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/NCT02980601
org study id: IRB00031531
secondary id: CCCWFU 99915A
nct id: NCT02980601
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this research study is to compare the forearm free flap of patients with a
      traditional split thickness skin graft and those repaired with Integra (a skin substitute
      that helps to provide wound closure) and a split thickness skin graft. The study team will be
      looking at the subject's satisfaction with how the skin graft site looks and how well the
      skin graft site is functioning.
The radial forearm fasciocutaneous free flap (hereafter referred to as RFFF) was described
      more than 30 years ago as a fasciocutaneous flap for microsurgical transfer. It was soon
      after established as a safe and reliable flap for transfer of fascia and cutaneous tissue.
      Currently, it is used to repair any defect in which a relatively thin island of skin is
      needed with a fascial strength layer . While the flap itself is very reliable, it leaves a
      donor site that can be very unsightly and has multiple known complications including loss of
      pronation, pain, paresthesias, cold intolerance, and skin graft necrosis. The donor site is
      typically covered with a split thickness skin graft (hereafter referred to as STSG). In an
      effort to minimize these complications, several groups have described a technique of placing
      Integra© dermal substitute (hereafter referred to as Integra) underneath the STSG to provide
      a thicker support and decrease overall morbidity associated with the defect. These studies
      have shown success in decreasing overall morbidity including increasing range of motion and
      improving aesthetic quality of the donor site. However, the largest study to date has
      included only 29 subjects. Furthermore, these studies do not provide a comparative cohort of
      subjects repaired with a classic STSG to show effectiveness of this technique when compared
      to a classic repair. Our goal is to perform a prospective study comparing subjects repaired
      with a classic STSG and those repaired with one step Integra and STSG applied at the same
      time. These subjects will be evaluated for overall donor site aesthetic quality and
      functional outcome as described below.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Participants With Skin Graft Necrosis.
time frame: 1 year
description: Number of participants with skin graft necrosis.
measure: Vancouver Scar Scale
time frame: 1 Year
description: The Vancouver Scar Scale will measure donor site aesethetic quality and it encompasses 4 separate outcomes to be objectively assessed. Each has been separately reported in the literature for each group in different papers as previously mentioned. We will compare the final score as well as scores within each outcome.On a scale of 1-13; with higher score denoting worse outcome.
measure: Vancouver Scar Scale - Pigmentation
time frame: 1 year
description: Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome.
measure: Vancouver Scar Scale - Vascularity
time frame: 1 year
description: Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.
measure: Vancouver Scar Scale - Pliability
time frame: 1 year
description: Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome.
measure: Vancouver Scar Scale - Height
time frame: 1 year
description: Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.
measure: Hand Strength -Lateral Pinch
time frame: Pre-op
description: Functional outcomes will be measured by using strength dynamometers.
measure: Hand Strength -Lateral Pinch
time frame: 3 month
description: Functional outcomes will be measured by using strength dynamometers.
measure: Hand Strength -Lateral Pinch
time frame: 6 months
description: Functional outcomes will be measured by using strength dynamometers.
measure: Hand Strength -Lateral Pinch
time frame: 1 year
description: Functional outcomes will be measured by using strength dynamometers.
measure: Hand Strength - Grip
time frame: pre-op
description: Functional outcomes will be measured by using strength dynamometers.
measure: Hand Strength - Grip
time frame: 3 month
description: Functional outcomes will be measured by using strength dynamometers.
measure: Hand Strength - Grip
time frame: 6 month
description: Functional outcomes will be measured by using strength dynamometers.
measure: Hand Strength - Grip
time frame: 1 year
description: Functional outcomes will be measured by using strength dynamometers.
measure: Hand Strength- Pincer
time frame: pre-op
description: Functional outcomes will be measured by using strength dynamometers
measure: Hand Strength- Pincer
time frame: 3 month
description: Functional outcomes will be measured by using strength dynamometers
measure: Hand Strength- Pincer
time frame: 6 month
description: Functional outcomes will be measured by using strength dynamometers
measure: Hand Strength- Pincer
time frame: 1 year
description: Functional outcomes will be measured by using strength dynamometers
measure: Wrist Range of Motion- Flexion
time frame: pre-op
description: Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
measure: Wrist Range of Motion- Flexion
time frame: 3 month
description: Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
measure: Wrist Range of Motion- Flexion
time frame: 6 month
description: Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
measure: Wrist Range of Motion- Flexion
time frame: 1 year
description: Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
measure: Wrist Range of Motion- Extension
time frame: pre-op
description: Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
measure: Wrist Range of Motion- Extension
time frame: 3 month
description: Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
measure: Wrist Range of Motion- Extension
time frame: 6 month
description: Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
measure: Wrist Range of Motion- Extension
time frame: 1 year
description: Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
measure: Number of Participant With Tendon Exposure
time frame: 6 month
description: Tendon exposure identified clinically.
measure: Rate of Tendon Exposure
time frame: 1 year
description: Tendon exposure identified clinically.
measure: Patient Scar Assessment- Paresthesia
time frame: 3 month
description: Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
measure: Patient Scar Assessment- Paresthesia
time frame: 6 month
description: Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
measure: Patient Scar Assessment- Paresthesia
time frame: 1 year
description: Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
measure: The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
time frame: pre-op
description: Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
measure: The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
time frame: 3 month
description: Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
measure: The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
time frame: 6 month
description: Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
measure: The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
time frame: 1 year
description: Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
measure: Percent of Wound Contracture
time frame: 3 month
description: Planimetry Software will be used to measure and determine percentage of wound contracture
measure: Percent of Wound Contracture
time frame: 6 month
description: Planimetry Software will be used to measure and determine percentage of wound contracture
measure: Percent of Wound Contracture
time frame: 1 year
description: Planimetry Software will be used to measure and determine percentage of wound contracture
measure: Skin Pliability
time frame: 1 year
description: Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf).
measure: Patient Scar Assessment
time frame: 3 month
description: Total score (20-200). Higher scores denote worse outcomes.
measure: Patient Scar Assessment
time frame: 6 month
description: Total score (20-200). Higher scores denote worse outcomes.
measure: Patient Scar Assessment
time frame: 1 year
description: Total score (20-200). Higher scores denote worse outcomes.
arm group label: Integra and a Split Thickness Skin Graft (STSG)
arm group type: Experimental
description: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.
arm group label: Split Thickness Skin Graft (STSG)
arm group type: Active Comparator
description: reconstruction as dictated by the protocol. They will either receive 1) a 0
intervention type: Device
intervention name: Integra plus STSG
description: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG
arm group label: Integra and a Split Thickness Skin Graft (STSG)
intervention type: Procedure
intervention name: STSG
description: 0.012mm STSG
arm group label: Integra and a Split Thickness Skin Graft (STSG)
arm group label: Split Thickness Skin Graft (STSG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph Molnar, MD, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 