Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure

Linear Cutaneous Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03294863
• Other study ID #: 101077
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: March 2028

Study information

• Verified date: June 2023
• Source: University of California, Davis
• Contact: Daniel B Eisen, MD
• Phone: 916-551-2636
• Email: dbeisen[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Linear Cutaneous Wound
• Wounds and Injuries

Intervention

Device:
• Embrace Scar Therapy Device
16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.

Other:
• Standard of Care
Without the embrace Scar Therapy Device

Locations

Country	Name	City	State
United States	University of California, Davis, Department of Dermatology	Sacramento	California
United States	University of California, Davis, Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician observer scar assessment score (POSAS)	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.	3 months
Primary	Width of the scar	The width of the scar on both sides will also be measured and recorded 1 cm from midline on both sides of the scar	3 months