Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure

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

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.

Study Overview

• Status: Recruiting
• Conditions: Linear Cutaneous Wound
• Intervention / Treatment: Device: Embrace Scar Therapy Device; Other: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel B Eisen, MD; Phone Number: 916-551-2636; Email: dbeisen@ucdavis.edu
• Study Contact Backup: Name: Iryna Rybak, BS; Phone Number: 916-551-2636; Email: irybak@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Recruiting
      • University of California, Davis, Department of Dermatology
      • Contact: Daniel Eisen, MD; Phone Number: 916-734-6479; Email: dbeisen@ucdavis.edu
      • Principal Investigator: Daniel Eisen, MD
      • Contact: Iryna Rybak, BS; Phone Number: 916-551-2636; Email: irybak@ucdavis.edu
    • Sacramento, California, United States, 95816
      • Enrolling by invitation
      • University of California, Davis, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Daniel B Eisen, MD, UC Davis

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Scar; Wound Closure; Cosmesis; Embrace Device; Split Wound; Cutaneous Wound
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 101077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes