An interventional study of Embrace Scar Therapy Device and Standard of Care in Linear Cutaneous Wound, sponsored by University of California, Davis. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University of California, Davis · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
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
Another 1/2 of cutaneous wound will be treated per standard of care
Other: Standard of Care
16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.
Without the embrace Scar Therapy Device
Physician Observer Scar Assessment Score (POSAS)
The 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.
Time frame: 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
Time frame: 3 months
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.
| Milestone | Embrace Scar Therapy Device | Standard of Care |
|---|---|---|
| Started | 49 | 49 |
| Completed | 20 | 20 |
| Not completed | 29 | 29 |
| Withdrew: Withdrawal by subject | 14 | 14 |
| Withdrew: Lost to follow-up | 15 | 15 |
The 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.
| score on a scale | Embrace Scar Therapy Device | Standard of Care |
|---|---|---|
| Physician Observer Scar Assessment Score (POSAS) | 20.45 ± 5.46 | 19.28 ± 6.84 |
The width of the scar on both sides will also be measured and recorded 1 cm from midline on both sides of the scar
| mm | Embrace Scar Therapy Device | Standard of Care |
|---|---|---|
| Width of the Scar | 1.62 ± 2.40 | 1.40 ± 2.31 |
Collected over Baseline Visit (Day 0) to Follow Up Visit (3 Months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Embrace Scar Therapy Device | 0/49 (0%) | 0/49 (0%) | 15/49 (30.6%) |
| Standard of Care | 0/49 (0%) | 0/49 (0%) | 8/49 (16.3%) |
| Event | Embrace Scar Therapy Device | Standard of Care |
|---|---|---|
| Adhesive ReactionSkin and subcutaneous tissue disorders | 9/49 | 5/49 |
| InfectionSkin and subcutaneous tissue disorders | 3/49 | 2/49 |
| Suture AbscessSkin and subcutaneous tissue disorders | 1/49 | 0/49 |
| Localized Pain at SiteSkin and subcutaneous tissue disorders | 1/49 | 0/49 |
| DehiscenceSkin and subcutaneous tissue disorders | 1/49 | 1/49 |
Out of 49 patients, each wound was split into half, with each side receiving one of the two interventions, in total having 98 half wounds.
| Age, Categorical(Wound Halves) | Embrace Scar Therapy Device | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 24 | 48 |
| >=65 years | 25 | 25 | 50 |
| Age, Continuous(years) | Embrace Scar Therapy Device | Standard of Care | Total |
|---|---|---|---|
| Mean | 61.55 ± 15.16 | 61.55 ± 15.16 | 61.55 ± 15.16 |
| Sex: Female, Male(Wound Halves) | Embrace Scar Therapy Device | Standard of Care | Total |
|---|---|---|---|
| Female | 26 | 26 | 52 |
| Male | 23 | 23 | 46 |
| Race (NIH/OMB)(Wound Halves) | Embrace Scar Therapy Device | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 47 | 47 | 94 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Region of Enrollment(Wound Halves) | Embrace Scar Therapy Device | Standard of Care | Total |
|---|---|---|---|
| United States | 49 | 49 | 98 |
| Location of Surgical Procedure(Wound Halves) | Embrace Scar Therapy Device | Standard of Care | Total |
|---|---|---|---|
| Cheek | 0 | 0 | 0 |
| Chin | 0 | 0 | 0 |
| Eyelids | 0 | 0 | 0 |
| Forehead | 0 | 0 | 0 |
| Lip | 0 | 0 | 0 |
| Neck | 1 | 1 | 2 |
| Preauricular | 0 | 0 | 0 |
| Post-auricular | 0 | 0 | 0 |
| Temple | 0 | 0 | 0 |
| Scalp | 0 | 0 | 0 |
| Chest | 9 | 9 | 18 |
| Shoulder | 3 | 3 | 6 |
| Back | 14 | 14 | 28 |
| Abdomen | 3 | 3 | 6 |
| Arm | 14 | 14 | 28 |
| Leg | 5 | 5 | 10 |
| Surgeon Experience(Wound Halves) | Embrace Scar Therapy Device | Standard of Care | Total |
|---|---|---|---|
| Fellow | 3 | 3 | 6 |
| Attending | 28 | 28 | 56 |
| Resident | 18 | 18 | 36 |
| Indication for Surgery(Wound Halves) | Embrace Scar Therapy Device | Standard of Care | Total |
|---|---|---|---|
| Mohs Surgery | 8 | 8 | 16 |
| Excision Surgery | 41 | 41 | 82 |
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University of California, Davis