Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure

NCT03294863 | Completed FDA Device

• 1 other identifier: 101077
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Linear Cutaneous Wound

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Embrace Scar Therapy Device

EXPERIMENTAL

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

Standard of Care

PLACEBO COMPARATOR

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

Other: Standard of Care

Interventions

Standard of Care OTHER

Without the embrace Scar Therapy Device

Standard of Care

Embrace Scar Therapy Device DEVICE

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

Embrace Scar Therapy Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Daniel B Eisen, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject receives both types of interventions upon the same scar in order for comparison.

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 27, 2017
• Study Start: March 15, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 8, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (1)