<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/NCT03294863</url>
  </required_header>
  <id_info>
    <org_study_id>101077</org_study_id>
    <nct_id>NCT03294863</nct_id>
  </id_info>
  <brief_title>Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure</brief_title>
  <official_title>Use of Embrace Device After Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>
      The purpose of this study is to determine whether the use of the embrace device after repair&#xD;
      of linear cutaneous surgery wounds improves scar cosmesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine whether the use of the embrace device after repair&#xD;
      of linear cutaneous surgery wounds improves scar cosmesis. We will use a split wound model,&#xD;
      half of the wound is treated with the embrace device and the other half is not treated.&#xD;
      Three-months post-surgery, the scar will be measured via the physician observer scar&#xD;
      assessment scale, a validated scar instrument. The scar width and adverse events will also be&#xD;
      recorded.&#xD;
&#xD;
      Following the surgical repair of cutaneous wounds, scar formation is inevitable and results&#xD;
      in varying degrees of aesthetic and/or functional impairment. Numerous treatment modalities&#xD;
      have been employed to treat scars. Carbon dioxide and pulse dye lasers, as well as&#xD;
      dermabrasion can reduce erythema and irregular topology of the scar surface1,2.&#xD;
      Silicone-based products have also been used to treat post-surgical scars, including gels,&#xD;
      sheets, and tape3-5. Intralesional steroids are often injected into to induce flattening of a&#xD;
      scar6. More recent research has highlighted the impact of mechanical forces and tension on&#xD;
      scar formation. In one report, incisions in both pigs and humans were treated with a&#xD;
      tension-shielding device and showed a reduction in scarring7. More recently two clinical&#xD;
      trials have been published in the plastic surgery literature showing that the use of the&#xD;
      embrace device, a silicone-based dressing designed to minimize wound tension, is effective in&#xD;
      improving the aesthetic outcome following scar revision surgery8,9. While these initial&#xD;
      studies of the embrace device have promising findings, there are significant drawbacks to&#xD;
      both studies including small study population, inclusion of patients seeking scar revision (a&#xD;
      select group likely predisposed to poor scar cosmesis and not representative of first-time&#xD;
      surgical patients), investigator conflict of interest, and the use of a digital&#xD;
      software-based scar assessment tool using patients photos that were not standardized with&#xD;
      respect to lighting or distance. Therefore, larger studies in first-time surgical patients&#xD;
      with standardized photos for scar assessment are required to validate this potentially&#xD;
      promising device for improved scar cosmesis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Anticipated">March 2028</completion_date>
  <primary_completion_date type="Anticipated">March 2028</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Each subject receives both types of interventions upon the same scar in order for comparison.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physician observer scar assessment score (POSAS)</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of scar cosmesis over area of wound that was treated with the device as compared to area that was not treated with the device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Width of the scar</measure>
    <time_frame>3 months</time_frame>
    <description>The width of the scar on both sides will also be measured and recorded 1 cm from midline on both sides of the scar</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Linear Cutaneous Wound</condition>
  <arm_group>
    <arm_group_label>Embrace Scar Therapy Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive will be applied to 1/2 of the cutaneous wound</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Another 1/2 of cutaneous wound will be treated per standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Embrace Scar Therapy Device</intervention_name>
    <description>16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.</description>
    <arm_group_label>Embrace Scar Therapy Device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Without the embrace Scar Therapy Device</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Able to give informed consent themselves&#xD;
&#xD;
          -  Patient scheduled for cutaneous surgical procedure along a flat surface suitable to&#xD;
             application of the embrace with predicted primary closure.&#xD;
&#xD;
          -  Able to apply dressings themselves.&#xD;
&#xD;
          -  Willing to return for follow up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mentally handicapped&#xD;
&#xD;
          -  Unable to understand written and oral English&#xD;
&#xD;
          -  Incarceration&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Pregnant Women&#xD;
&#xD;
          -  Wounds with predicted closure length less than 3 cm&#xD;
&#xD;
          -  Patients with known adverse reactions to adhesives&#xD;
&#xD;
          -  Patients with history of collagen vascular disease&#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>Daniel B Eisen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Davis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel B Eisen, MD</last_name>
    <phone>916-551-2636</phone>
    <email>dbeisen@ucdavis.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Iryna Rybak, BS</last_name>
    <phone>916-551-2636</phone>
    <email>irybak@ucdavis.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California, Davis, Department of Dermatology</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>University of California, Davis, Department of Dermatology</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Eisen, MD</last_name>
      <phone>916-734-6479</phone>
      <email>dbeisen@ucdavis.edu</email>
    </contact>
    <contact_backup>
      <last_name>Iryna Rybak, BS</last_name>
      <phone>916-551-2636</phone>
      <email>irybak@ucdavis.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Daniel Eisen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Scar</keyword>
  <keyword>Cosmesis</keyword>
  <keyword>Embrace Device</keyword>
  <keyword>Split Wound</keyword>
  <keyword>Wound Closure</keyword>
  <keyword>Cutaneous Wound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03294863
org study id: 101077
nct id: NCT03294863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to determine whether the use of the embrace device after repair
      of linear cutaneous surgery wounds improves scar cosmesis.
The purpose of this study is to determine whether the use of the embrace device after repair
      of linear cutaneous surgery wounds improves scar cosmesis. We will use a split wound model,
      half of the wound is treated with the embrace device and the other half is not treated.
      Three-months post-surgery, the scar will be measured via the physician observer scar
      assessment scale, a validated scar instrument. The scar width and adverse events will also be
      recorded.

      Following the surgical repair of cutaneous wounds, scar formation is inevitable and results
      in varying degrees of aesthetic and/or functional impairment. Numerous treatment modalities
      have been employed to treat scars. Carbon dioxide and pulse dye lasers, as well as
      dermabrasion can reduce erythema and irregular topology of the scar surface1,2.
      Silicone-based products have also been used to treat post-surgical scars, including gels,
      sheets, and tape3-5. Intralesional steroids are often injected into to induce flattening of a
      scar6. More recent research has highlighted the impact of mechanical forces and tension on
      scar formation. In one report, incisions in both pigs and humans were treated with a
      tension-shielding device and showed a reduction in scarring7. More recently two clinical
      trials have been published in the plastic surgery literature showing that the use of the
      embrace device, a silicone-based dressing designed to minimize wound tension, is effective in
      improving the aesthetic outcome following scar revision surgery8,9. While these initial
      studies of the embrace device have promising findings, there are significant drawbacks to
      both studies including small study population, inclusion of patients seeking scar revision (a
      select group likely predisposed to poor scar cosmesis and not representative of first-time
      surgical patients), investigator conflict of interest, and the use of a digital
      software-based scar assessment tool using patients photos that were not standardized with
      respect to lighting or distance. Therefore, larger studies in first-time surgical patients
      with standardized photos for scar assessment are required to validate this potentially
      promising device for improved scar cosmesis.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Each subject receives both types of interventions upon the same scar in order for comparison.
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Physician observer scar assessment score (POSAS)
time frame: 3 months
description: Comparison of scar cosmesis over area of wound that was treated with the device as compared to area that was not treated with the device.
measure: Width of the scar
time frame: 3 months
description: The width of the scar on both sides will also be measured and recorded 1 cm from midline on both sides of the scar
arm group label: Embrace Scar Therapy Device
arm group type: Experimental
description: 16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive will be applied to 1/2 of the cutaneous wound
arm group label: Standard of Care
arm group type: Placebo Comparator
description: Another 1/2 of cutaneous wound will be treated per standard of care
intervention type: Device
intervention name: Embrace Scar Therapy Device
description: 16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.
arm group label: Embrace Scar Therapy Device
intervention type: Other
intervention name: Standard of Care
description: Without the embrace Scar Therapy Device
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel B Eisen, MD
role: Principal Investigator
affiliation: UC Davis
last name: Daniel B Eisen, MD
phone: 916-551-2636
email: dbeisen@ucdavis.edu
last name: Iryna Rybak, BS
phone: 916-551-2636
email: irybak@ucdavis.edu
facility: 
status: Enrolling by invitation
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: Undecided