<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/NCT03285698</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0061</org_study_id>
    <nct_id>NCT03285698</nct_id>
  </id_info>
  <brief_title>Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix</brief_title>
  <official_title>A Randomized, Prospective Trial Comparing the Clinical Outcomes for DermACELL® Compared With Integra® Bilayer Wound Matrix</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LifeNet Health</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Georgetown University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Both DermACELL® and Integra® Bilayer Wound Matrix are indicated for deep soft tissue coverage&#xD;
      and serve as a biological matrix for cellular migration. The current thinking about the&#xD;
      utility of these products is to apply over the wound surface and wait until the graft is well&#xD;
      vascularized (granular bed/neodermis). At that point a split thickness skin graft can be&#xD;
      applied over this area to cover and heal the wound. This study will determine whether human&#xD;
      allograft or xenograft will create a durable neodermis that is more supportive of accepting&#xD;
      of a split thickness skin graft. Patients who do not receive Split thickness skin grafts will&#xD;
      be assigned to the second cohort for observation of healing rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, single site, clinical research trial comparing the&#xD;
      clinical outcomes of DermACELL® compared with Integra® Bilayer Wound Matrix in dermal&#xD;
      regeneration. A total of 100 subjects will be randomized into either the DermACELL® (n=50) or&#xD;
      Integra® Bilayer Wound Matrix (n=50) treatment group. An interim analysis will be performed&#xD;
      when both groups have enrolled 25 subjects. Subjects will receive either DermACELL® or&#xD;
      Integra® Bilayer Wound Matrix in the operating room for coverage of deep soft tissue defects&#xD;
      in the lower extremity. Subjects will then be followed in the outpatient clinic. Once the&#xD;
      neodermis has been sufficiently generated, a split thickness skin graft (autograft or&#xD;
      allograft) will be applied in the operating room. The split thickness skin graft application&#xD;
      site will be then followed to observe viability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 18, 2014</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Photographs are submitted and evaluated by a blind, independent assessor.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time the wound bed takes to heal for split thickness skin graft application</measure>
    <time_frame>160 days</time_frame>
    <description>Time (days) required for wound bed preparation (granular bed) for the application of a split thickness skin graft (autograft or allograft) after placement of DermACELL® as compared with Integra® Bilayer Wound Matrix.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with complete split thickness skin graft take</measure>
    <time_frame>30 days</time_frame>
    <description>The percent of subjects with complete split thickness skin graft (autograft or allograft) take utilizing DermACELL® as compared with Integra® Bilayer Wound Matrix 30 days after split thickness skin graft application.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of split thickness skin graft take for wound</measure>
    <time_frame>30 days</time_frame>
    <description>The percent of split thickness skin graft (autograft or allograft) take for a wound that receives DermACELL® as compared with Integra® Bilayer Wound Matrix 30 days after split thickness skin graft application.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">53</enrollment>
  <condition>Wounds</condition>
  <condition>Chronic Wounds</condition>
  <condition>Nonmalignant Condition</condition>
  <arm_group>
    <arm_group_label>Integra®</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Integra® is a bilayer wound matrix made out of bovine tissue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DermACELL®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DermACELL® is a bilayer wound matrix made out of human tissue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DermACELL®</intervention_name>
    <description>DermACELL® is a bilayer wound matrix made out of human tissue and is applied to the wound in standard of care fashion.</description>
    <arm_group_label>DermACELL®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Integra®</intervention_name>
    <description>Integra® is a bilayer wound matrix made out of bovine tissue and is applied to the wound in standard of care fashion.</description>
    <arm_group_label>Integra®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. male or female 18-90&#xD;
&#xD;
          2. who have a complex soft tissue defect that extends below subcutaneous tissue (exposed&#xD;
             fascia, ligament, tendon, muscle, or bone)&#xD;
&#xD;
          3. wounds that are either acute or chronic (nonhealing wounds greater than 4 weeks but&#xD;
             not greater than 2 years in duration)&#xD;
&#xD;
          4. wounds not amendable to primary closure as deemed by the surgeon&#xD;
&#xD;
          5. wounds that have been deemed by the surgeon that any residual infection has been or is&#xD;
             being treated upon entry into the clinical trial&#xD;
&#xD;
          6. requiring operative application of a dermoconductive agent&#xD;
&#xD;
          7. extremity wounds have adequate perfusion determined by: palpable pedal pulses,&#xD;
             dopplerable pulses, ankle brachial index of &gt;0.7, or transcutaneous oximetry of &gt;0.5&#xD;
&#xD;
          8. renally stable (i.e. CR&lt;3.0, BUN&gt;9.0, eGFR &gt;60)&#xD;
&#xD;
          9. is able to comply to clinical trial requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. with a contraindication for the application of a xenograft or allograft&#xD;
&#xD;
          2. untreated infection of soft tissue or bone&#xD;
&#xD;
          3. untreated autoimmune connective tissue disorders&#xD;
&#xD;
          4. body mass index of ≥ 50&#xD;
&#xD;
          5. undergoing chemotherapy/radiation therapy&#xD;
&#xD;
          6. malignancy&#xD;
&#xD;
          7. active liver disease (e.g. hepatitis A-G),&#xD;
&#xD;
          8. previous wound care therapy that included any bioengineered alternative tissue or STSG&#xD;
             30 days prior to enrollment&#xD;
&#xD;
          9. pregnancy&#xD;
&#xD;
         10. enrolled in any other interventional clinical research trial&#xD;
&#xD;
         11. unable or unwilling to comply with study requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Attinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgetown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medstar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Georgetown University</investigator_affiliation>
    <investigator_full_name>Christopher Attinger, M.D.</investigator_full_name>
    <investigator_title>Chief, Division of Reconstructive Plastic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Precancerous Conditions</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03285698
org study id: 2014-0061
nct id: NCT03285698
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Both DermACELL® and Integra® Bilayer Wound Matrix are indicated for deep soft tissue coverage
      and serve as a biological matrix for cellular migration. The current thinking about the
      utility of these products is to apply over the wound surface and wait until the graft is well
      vascularized (granular bed/neodermis). At that point a split thickness skin graft can be
      applied over this area to cover and heal the wound. This study will determine whether human
      allograft or xenograft will create a durable neodermis that is more supportive of accepting
      of a split thickness skin graft. Patients who do not receive Split thickness skin grafts will
      be assigned to the second cohort for observation of healing rates.
This is a prospective, randomized, single site, clinical research trial comparing the
      clinical outcomes of DermACELL® compared with Integra® Bilayer Wound Matrix in dermal
      regeneration. A total of 100 subjects will be randomized into either the DermACELL® (n=50) or
      Integra® Bilayer Wound Matrix (n=50) treatment group. An interim analysis will be performed
      when both groups have enrolled 25 subjects. Subjects will receive either DermACELL® or
      Integra® Bilayer Wound Matrix in the operating room for coverage of deep soft tissue defects
      in the lower extremity. Subjects will then be followed in the outpatient clinic. Once the
      neodermis has been sufficiently generated, a split thickness skin graft (autograft or
      allograft) will be applied in the operating room. The split thickness skin graft application
      site will be then followed to observe viability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Photographs are submitted and evaluated by a blind, independent assessor.
measure: Time the wound bed takes to heal for split thickness skin graft application
time frame: 160 days
description: Time (days) required for wound bed preparation (granular bed) for the application of a split thickness skin graft (autograft or allograft) after placement of DermACELL® as compared with Integra® Bilayer Wound Matrix.
measure: Percentage of subjects with complete split thickness skin graft take
time frame: 30 days
description: The percent of subjects with complete split thickness skin graft (autograft or allograft) take utilizing DermACELL® as compared with Integra® Bilayer Wound Matrix 30 days after split thickness skin graft application.
measure: Percentage of split thickness skin graft take for wound
time frame: 30 days
description: The percent of split thickness skin graft (autograft or allograft) take for a wound that receives DermACELL® as compared with Integra® Bilayer Wound Matrix 30 days after split thickness skin graft application.
arm group label: Integra®
arm group type: Other
description: Integra® is a bilayer wound matrix made out of bovine tissue.
arm group label: DermACELL®
arm group type: Experimental
description: DermACELL® is a bilayer wound matrix made out of human tissue.
intervention type: Device
intervention name: DermACELL®
description: DermACELL® is a bilayer wound matrix made out of human tissue and is applied to the wound in standard of care fashion.
arm group label: DermACELL®
intervention type: Device
intervention name: Integra®
description: Integra® is a bilayer wound matrix made out of bovine tissue and is applied to the wound in standard of care fashion.
arm group label: Integra®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Christopher Attinger, MD
role: Principal Investigator
affiliation: Georgetown University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Georgetown University
investigator full name: Christopher Attinger, M.D.
investigator title: Chief, Division of Reconstructive Plastic Surgery
mesh term: Precancerous Conditions
mesh term: Wounds and Injuries