<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/NCT04456127</url>
  </required_header>
  <id_info>
    <org_study_id>2018-063</org_study_id>
    <nct_id>NCT04456127</nct_id>
  </id_info>
  <brief_title>CO2 Laser Revision for Burn Related Donor Site Scars</brief_title>
  <official_title>Ablative Fractional CO2 Laser Revision for Burn Related Donor Site Scars: A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medstar Health Research Institute</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn&#xD;
      wounds may be left to heal by secondary intention or treated with surgical skin grafting; in&#xD;
      both circumstances, significant scars likely result. When surgical skin grafting is employed,&#xD;
      skin graft harvest sites (&quot;donor sites&quot;) likewise result in clinically significant scars.&#xD;
&#xD;
      This study will have interventional and observational components. Patients will receive the&#xD;
      standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed&#xD;
      to heal by secondary intention and/or those treated with skin grafts. These will be&#xD;
      prospectively observed for the duration of the study as well as adjacent normal skin. In&#xD;
      addition, a donor site that meets inclusion criteria that would not have otherwise received&#xD;
      LSR will be identified as a treatment site. Patients with have one half of their donor sites&#xD;
      randomized to standard of care (SOC) treatment, which consists of wound dressings,&#xD;
      compression therapy, physical and occupational therapies and the other half randomized to SOC&#xD;
      + ablative fractional CO2 laser therapy (LSR).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 21, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2023</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>
    <intervention_model_description>Intra-subject comparison</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of Patient and Observer Scar Assessment Scale, VSS, and Delfin Instruments</measure>
    <time_frame>2 months</time_frame>
    <description>The primary endpoint will be assessment of control and treatment halves at follow-up evaluation completed 2 months ± 2 weeks after the final laser treatment.&#xD;
The change in scale measure from baseline to date of assessment will be used to compare treatment vs control scar halves. This will be calculated and compared using paired t-test with a p-value of 0.05 as the cutoff for significance.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Burn Scar</condition>
  <condition>Scar</condition>
  <condition>Skin Graft Scar</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Scar section does not receive CO2 laser therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Factional CO2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Scar section receives fractional CO2 laser therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fractional CO2 Laser</intervention_name>
    <description>The UltraPulse® fractional ablative CO2 Laser will be employed with the DeepFX™ hand piece. Number of passes and laser settings, including fluency, density, spot size, will be chosen during the time of treatment as determined by the operating surgeon.</description>
    <arm_group_label>Factional CO2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  At least 1 second or third degree burn wound that required treatment with&#xD;
             split-thickness skin grafts&#xD;
&#xD;
          -  Donor site with at least a 4 x 4 inch surface area&#xD;
&#xD;
          -  Able to return to clinical site for treatments and assessments of burn injuries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or nursing&#xD;
&#xD;
          -  Oral retinoid medication use within the past 6 months&#xD;
&#xD;
          -  Medical history of Ehlers-Danlos syndrome, AIDS&#xD;
&#xD;
          -  Nutritional deficiencies in the opinion of the investigator that would affect wound&#xD;
             healing&#xD;
&#xD;
          -  Wounds complicated by clinically significant infection within past 30 days&#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_contact>
    <last_name>Melissa M McLawhorn</last_name>
    <phone>202-877-6181</phone>
    <email>Melissa.M.Mclawhorn@medstar.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa M McLawhorn, RN</last_name>
      <phone>202-877-6181</phone>
    </contact>
    <investigator>
      <last_name>Taryn E Travis, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</mesh_term>
    <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/NCT04456127
org study id: 2018-063
nct id: NCT04456127
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn
      wounds may be left to heal by secondary intention or treated with surgical skin grafting; in
      both circumstances, significant scars likely result. When surgical skin grafting is employed,
      skin graft harvest sites ("donor sites") likewise result in clinically significant scars.

      This study will have interventional and observational components. Patients will receive the
      standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed
      to heal by secondary intention and/or those treated with skin grafts. These will be
      prospectively observed for the duration of the study as well as adjacent normal skin. In
      addition, a donor site that meets inclusion criteria that would not have otherwise received
      LSR will be identified as a treatment site. Patients with have one half of their donor sites
      randomized to standard of care (SOC) treatment, which consists of wound dressings,
      compression therapy, physical and occupational therapies and the other half randomized to SOC
      + ablative fractional CO2 laser therapy (LSR).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intra-subject comparison
primary purpose: Basic Science
masking: None (Open Label)
measure: Comparison of Patient and Observer Scar Assessment Scale, VSS, and Delfin Instruments
time frame: 2 months
description: The primary endpoint will be assessment of control and treatment halves at follow-up evaluation completed 2 months ± 2 weeks after the final laser treatment.
The change in scale measure from baseline to date of assessment will be used to compare treatment vs control scar halves. This will be calculated and compared using paired t-test with a p-value of 0.05 as the cutoff for significance.
arm group label: Standard of Care
arm group type: No Intervention
description: Scar section does not receive CO2 laser therapy.
arm group label: Factional CO2
arm group type: Experimental
description: Scar section receives fractional CO2 laser therapy.
intervention type: Procedure
intervention name: Fractional CO2 Laser
description: The UltraPulse® fractional ablative CO2 Laser will be employed with the DeepFX™ hand piece. Number of passes and laser settings, including fluency, density, spot size, will be chosen during the time of treatment as determined by the operating surgeon.
arm group label: Factional CO2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Melissa M McLawhorn
phone: 202-877-6181
email: Melissa.M.Mclawhorn@medstar.net
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Cicatrix
mesh term: Burns
sharing ipd: No