Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure

NCT ID: NCT03294863

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2025-12-15

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.

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.

Conditions

Linear Cutaneous Wound

Keywords

Scar; Cosmesis; Embrace Device; Split Wound; Wound Closure; Cutaneous Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Embrace Scar Therapy Device

Intervention Type: DEVICE

16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.

Standard of Care

Another 1/2 of cutaneous wound will be treated per standard of care

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: OTHER

Without the embrace Scar Therapy Device

Interventions

Embrace Scar Therapy Device

16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.

Intervention Type: DEVICE

Standard of Care

Without the embrace Scar Therapy Device

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel B Eisen, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

University of California, Davis, Department of Dermatology

Sacramento, California, United States

Countries

United States

Other Identifiers

101077

Identifier Type: -

Identifier Source: org_study_id