Summary

for people ages 18 years and up (full criteria)
at Sacramento, California
study started
estimated completion

Description

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.

Official Title

Use of Embrace Device After Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial

Details

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.

Keywords

Linear Cutaneous Wound Scar Cosmesis Embrace Device Split Wound Wound Closure Cutaneous Wound Wounds and Injuries Embrace Scar Therapy Device

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Location

  • University of California, Davis, Department of Dermatology accepting new patients
    Sacramento California 95816 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT03294863
Study Type
Interventional
Last Updated