Skip to content

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03294863
Enrollment
49
Registered
2017-09-27
Start date
2017-03-15
Completion date
2025-12-08
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Linear Cutaneous Wound

Keywords

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

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.

Interventions

DEVICEEmbrace Scar Therapy Device

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

OTHERStandard of Care

Without the embrace Scar Therapy Device

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physician Observer Scar Assessment Score (POSAS)3 monthsThe Patient Observer Scar Assessment Score (POSAS) will be used to compare the cosmetic appearance of scars in the area treated with the device versus the area that was not treated. The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes.
Width of the Scar3 monthsThe width of the scar on both sides will also be measured and recorded 1 cm from midline on both sides of the scar

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDaniel B Eisen, MD

UC Davis

Participant flow

Recruitment details

Participants recruited for the study had their scars divided into two sections, labeled A and B. These sections were randomized, with one section receiving standard care while the other received the study intervention. A total of 49 participants were included in the study, resulting in 98 wound halves assessed at baseline.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Wound Halves
Age, Categorical
>=65 years
25 Wound Halves
Age, Categorical
Between 18 and 65 years
24 Wound Halves
Age, Continuous61.55 years
STANDARD_DEVIATION 15.16
Indication for Surgery
Excision Surgery
41 Wound Halves
Indication for Surgery
Mohs Surgery
8 Wound Halves
Location of Surgical Procedure
Abdomen
3 Wound Halves
Location of Surgical Procedure
Arm
14 Wound Halves
Location of Surgical Procedure
Back
14 Wound Halves
Location of Surgical Procedure
Cheek
0 Wound Halves
Location of Surgical Procedure
Chest
9 Wound Halves
Location of Surgical Procedure
Chin
0 Wound Halves
Location of Surgical Procedure
Eyelids
0 Wound Halves
Location of Surgical Procedure
Forehead
0 Wound Halves
Location of Surgical Procedure
Leg
10 Wound Halves
Location of Surgical Procedure
Lip
0 Wound Halves
Location of Surgical Procedure
Neck
2 Wound Halves
Location of Surgical Procedure
Post-auricular
0 Wound Halves
Location of Surgical Procedure
Preauricular
0 Wound Halves
Location of Surgical Procedure
Scalp
0 Wound Halves
Location of Surgical Procedure
Shoulder
3 Wound Halves
Location of Surgical Procedure
Temple
0 Wound Halves
Race (NIH/OMB)
American Indian or Alaska Native
0 Wound Halves
Race (NIH/OMB)
Asian
0 Wound Halves
Race (NIH/OMB)
Black or African American
0 Wound Halves
Race (NIH/OMB)
More than one race
0 Wound Halves
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Wound Halves
Race (NIH/OMB)
Unknown or Not Reported
2 Wound Halves
Race (NIH/OMB)
White
47 Wound Halves
Region of Enrollment
United States
49 Wound Halves
Sex: Female, Male
Female
26 Wound Halves
Sex: Female, Male
Male
23 Wound Halves
Surgeon Experience
Attending
28 Wound Halves
Surgeon Experience
Fellow
6 Wound Halves
Surgeon Experience
Resident
18 Wound Halves

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 490 / 49
other
Total, other adverse events
15 / 498 / 49
serious
Total, serious adverse events
0 / 490 / 49

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026