<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/NCT02982096</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00003893</org_study_id>
    <nct_id>NCT02982096</nct_id>
  </id_info>
  <brief_title>Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique</brief_title>
  <official_title>Randomized Controlled Pilot Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique (Membrane or Cream Dressings) in Superficial to Mid-dermal Burn Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lehigh Valley Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lehigh Valley Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if healing occurs within 21 days of treatment with&#xD;
      the use of the CellutomeTM device for fractional epidermal micro grafting compared with&#xD;
      standard acellular techniques (creams and membrane dressings).&#xD;
&#xD;
      Healing will be determined by time to ≥90% epithelialization within 21 days of treatment.&#xD;
      Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale&#xD;
      (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to&#xD;
      standard techniques without application of skin cells (epidermal grafts = acellular) and will&#xD;
      be measured twelve months post treatment application, ± 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis:&#xD;
&#xD;
      The use of epidermal blister grafting by the CellutomeTM device in the treatment of&#xD;
      superficial and mid-dermal burn wounds will demonstrate a difference in time to healing&#xD;
      compared to burn wounds treated with standard acellular technique.&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      Determine if the use of the CellutomeTM device will demonstrate a difference in healing time&#xD;
      compared to standard acellular technique. Final cosmetic outcomes (as assessed by Vancouver&#xD;
      Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation,&#xD;
      elasticity, thickness, and sensation) will be assessed and described at 12 months ± 6 months&#xD;
      post treatment.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  Determine if donor sites have any visible scarring with the use of the CellutomeTM.&#xD;
&#xD;
        -  Determine acute outcomes of therapy such as time to healing as assessed by ≥90%&#xD;
           epithelialization.&#xD;
&#xD;
        -  Determine chronic outcomes of therapy (as assessed by Vancouver Scar Scale (VSS),&#xD;
           Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity,&#xD;
           thickness, and sensation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2016</start_date>
  <completion_date type="Actual">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Healing time comparison of the donor site wound at 12 months post baseline.</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed by Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healing time comparison of the donor site wound at 12 months post baseline.</measure>
    <time_frame>12 Months</time_frame>
    <description>Assessed by Patient Observer Scar Assessment Scale (POSAS - evaluating patient perception of the scar including pain; itching; color; stiffness; thickness; irregularity on a 1-10 Likert Scale)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healing time comparison of the donor site wound at 12 months post baseline.</measure>
    <time_frame>12 Months</time_frame>
    <description>Visual assessment of Erythema of the donor site as compared to healthy skin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healing time comparison of the donor site wound at 12 months post baseline.</measure>
    <time_frame>12 Months</time_frame>
    <description>Assessed by measuring Elasticity (measured with cutometer) compared to healthy skin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healing time comparison of the donor site wound at 12 months post baseline</measure>
    <time_frame>12 Months</time_frame>
    <description>Visual assessment of Pigmentation of the donor site as compared to healthy skin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healing time comparison of the donor site wound at 12 months post baseline.</measure>
    <time_frame>12 Months</time_frame>
    <description>Thickness of donor site (measured by ultrasound) compared to healthy skin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healing time comparison of the donor site wound at 12 months post baseline.</measure>
    <time_frame>12 Months</time_frame>
    <description>Sensation of donor site (measured by the Semmes-Weinstein filament tool) compared to healthy skin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of visible scarring with the use of the CellutomeTM 12 months post baseline</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of impact of therapy on time to healing as assessed by ≥90% epithelialization 12 months post baseline.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic outcomes of therapy 12 months post baseline</measure>
    <time_frame>12 Months</time_frame>
    <description>Assessed by the following: Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic outcomes of therapy 12 months post baseline</measure>
    <time_frame>12 Months</time_frame>
    <description>Patient Observer Scar Assessment Scale (POSAS - evaluating patient perception of the scar including pain; itching; color; stiffness; thickness; irregularity on a 1-10 Likert Scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic outcomes of therapy 12 months post baseline</measure>
    <time_frame>12 Months</time_frame>
    <description>Visual assessment of Erythema of the donor site as compared to healthy skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic outcomes of therapy 12 months post baseline</measure>
    <time_frame>12 Months</time_frame>
    <description>Visual assessment of Pigmentation of the donor site as compared to healthy skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic outcomes of therapy 12 months post baseline</measure>
    <time_frame>12 Months</time_frame>
    <description>Elasticity of the donor site (measured with cutometer) compared to healthy skin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic outcomes of therapy 12 months post baseline</measure>
    <time_frame>12 Months</time_frame>
    <description>Thickness (measured with ultrasound) compared to healthy skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic outcomes of therapy 12 months post baseline</measure>
    <time_frame>12 Months</time_frame>
    <description>Sensation (measured by Semmes-Weinstein) compared to healthy skin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Burn Wound</condition>
  <arm_group>
    <arm_group_label>Cellutome treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cellutome Device: Use of Cellutome on burn wounds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard of Care: Acellular wound management</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cellutome Device</intervention_name>
    <description>Use of FDA approved Cellutome treatment on burn wounds</description>
    <arm_group_label>Cellutome treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Acellular burn wound management</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients admitted or seen by the LVHN Burn Service with superficial to mid-dermal&#xD;
             thickness burns will be considered for the study.&#xD;
&#xD;
          2. Age ≥18 years old.&#xD;
&#xD;
          3. Patients with a total body surface area (TBSA) burn &gt; 1% outside of the face, neck,&#xD;
             feet or genitalia, where at least 2 areas are greater in size than 5x5cm2 or at least&#xD;
             one area that is greater than 10cm2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant.&#xD;
&#xD;
          2. Age &lt; 18 years old.&#xD;
&#xD;
          3. Proposed study area on face, neck, genitalia, or feet.&#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>Sigrid Blome-Eberwein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lehigh Valley Health Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>April 7, 2023</last_update_submitted>
  <last_update_submitted_qc>April 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02982096
org study id: PRO00003893
nct id: NCT02982096
lead sponsor: 
has dmc: No
The purpose of this study is to determine if healing occurs within 21 days of treatment with
      the use of the CellutomeTM device for fractional epidermal micro grafting compared with
      standard acellular techniques (creams and membrane dressings).

      Healing will be determined by time to ≥90% epithelialization within 21 days of treatment.
      Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale
      (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to
      standard techniques without application of skin cells (epidermal grafts = acellular) and will
      be measured twelve months post treatment application, ± 6 months.
Hypothesis:

      The use of epidermal blister grafting by the CellutomeTM device in the treatment of
      superficial and mid-dermal burn wounds will demonstrate a difference in time to healing
      compared to burn wounds treated with standard acellular technique.

      Primary objective:

      Determine if the use of the CellutomeTM device will demonstrate a difference in healing time
      compared to standard acellular technique. Final cosmetic outcomes (as assessed by Vancouver
      Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation,
      elasticity, thickness, and sensation) will be assessed and described at 12 months ± 6 months
      post treatment.

      Secondary objectives:

        -  Determine if donor sites have any visible scarring with the use of the CellutomeTM.

        -  Determine acute outcomes of therapy such as time to healing as assessed by ≥90%
           epithelialization.

        -  Determine chronic outcomes of therapy (as assessed by Vancouver Scar Scale (VSS),
           Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity,
           thickness, and sensation).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Healing time comparison of the donor site wound at 12 months post baseline.
time frame: 12 months
description: Assessed by Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)
measure: Healing time comparison of the donor site wound at 12 months post baseline.
time frame: 12 Months
description: Assessed by Patient Observer Scar Assessment Scale (POSAS - evaluating patient perception of the scar including pain; itching; color; stiffness; thickness; irregularity on a 1-10 Likert Scale)
measure: Healing time comparison of the donor site wound at 12 months post baseline.
time frame: 12 Months
description: Visual assessment of Erythema of the donor site as compared to healthy skin
measure: Healing time comparison of the donor site wound at 12 months post baseline.
time frame: 12 Months
description: Assessed by measuring Elasticity (measured with cutometer) compared to healthy skin.
measure: Healing time comparison of the donor site wound at 12 months post baseline
time frame: 12 Months
description: Visual assessment of Pigmentation of the donor site as compared to healthy skin
measure: Healing time comparison of the donor site wound at 12 months post baseline.
time frame: 12 Months
description: Thickness of donor site (measured by ultrasound) compared to healthy skin
measure: Healing time comparison of the donor site wound at 12 months post baseline.
time frame: 12 Months
description: Sensation of donor site (measured by the Semmes-Weinstein filament tool) compared to healthy skin
measure: Comparison of visible scarring with the use of the CellutomeTM 12 months post baseline
time frame: 12 months
measure: Comparison of impact of therapy on time to healing as assessed by ≥90% epithelialization 12 months post baseline.
time frame: 12 months
measure: Comparison of chronic outcomes of therapy 12 months post baseline
time frame: 12 Months
description: Assessed by the following: Vancouver Scar Scale (Vascularity 0-3; Pigmentation 0-3; Pliability 0-5; and Height 0-4)
measure: Comparison of chronic outcomes of therapy 12 months post baseline
time frame: 12 Months
description: Patient Observer Scar Assessment Scale (POSAS - evaluating patient perception of the scar including pain; itching; color; stiffness; thickness; irregularity on a 1-10 Likert Scale)
measure: Comparison of chronic outcomes of therapy 12 months post baseline
time frame: 12 Months
description: Visual assessment of Erythema of the donor site as compared to healthy skin
measure: Comparison of chronic outcomes of therapy 12 months post baseline
time frame: 12 Months
description: Visual assessment of Pigmentation of the donor site as compared to healthy skin
measure: Comparison of chronic outcomes of therapy 12 months post baseline
time frame: 12 Months
description: Elasticity of the donor site (measured with cutometer) compared to healthy skin.
measure: Comparison of chronic outcomes of therapy 12 months post baseline
time frame: 12 Months
description: Thickness (measured with ultrasound) compared to healthy skin
measure: Comparison of chronic outcomes of therapy 12 months post baseline
time frame: 12 Months
description: Sensation (measured by Semmes-Weinstein) compared to healthy skin
arm group label: Cellutome treatment
arm group type: Active Comparator
description: Cellutome Device: Use of Cellutome on burn wounds
arm group label: Standard of Care
arm group type: Other
description: Standard of Care: Acellular wound management
intervention type: Device
intervention name: Cellutome Device
description: Use of FDA approved Cellutome treatment on burn wounds
arm group label: Cellutome treatment
intervention type: Other
intervention name: Standard of Care
description: Acellular burn wound management
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sigrid Blome-Eberwein, MD
role: Principal Investigator
affiliation: Lehigh Valley Health Network
facility: 
country: United States
responsible party type: Sponsor
mesh term: Burns
sharing ipd: No