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Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294863
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Linear Cutaneous Wound Device: Embrace Scar Therapy Device Other: Standard of Care Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Each subject receives both types of interventions upon the same scar in order for comparison.
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Use of Embrace Device After Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : March 2028
Estimated Study Completion Date : March 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Embrace Scar Therapy Device
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
Device: Embrace Scar Therapy Device
16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.

Placebo Comparator: Standard of Care
Another 1/2 of cutaneous wound will be treated per standard of care
Other: Standard of Care
Without the embrace Scar Therapy Device




Primary Outcome Measures :
  1. Physician observer scar assessment score (POSAS) [ Time Frame: 3 months ]
    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.

  2. Width of the scar [ Time Frame: 3 months ]
    The width of the scar on both sides will also be measured and recorded 1 cm from midline on both sides of the scar



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Able to give informed consent themselves
  • Patient scheduled for cutaneous surgical procedure along a flat surface suitable to application of the embrace with predicted primary closure.
  • Able to apply dressings themselves.
  • Willing to return for follow up visits.

Exclusion Criteria:

  • Mentally handicapped
  • Unable to understand written and oral English
  • Incarceration
  • Under 18 years of age
  • Pregnant Women
  • Wounds with predicted closure length less than 3 cm
  • Patients with known adverse reactions to adhesives
  • Patients with history of collagen vascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294863


Contacts
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Contact: Daniel B Eisen, MD (916)734-6479 dbeisen@ucdavis.edu
Contact: Simran Dhaliwal, BS (916) 734-6556 skdhali@ucdavis.edu

Locations
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United States, California
University of California, Davis, Department of Dermatology Recruiting
Sacramento, California, United States, 95816
Contact: Daniel Eisen, MD    916-734-6479    dbeisen@ucdavis.edu   
Contact: Simran Dhaliwal, BS    (916) 734-6556    skdhali@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Daniel B Eisen, MD UC Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03294863    
Other Study ID Numbers: 101077
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of California, Davis:
Scar
Cosmesis
Embrace Device
Split Wound
Wound Closure
Cutaneous Wound
Additional relevant MeSH terms:
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Wounds and Injuries