Trial Outcomes & Findings for Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure (NCT NCT03294863)

Last Updated: 2026-06-10

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

3 months

Results posted on

2026-06-10

Participant Flow

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.

Unit of analysis: Wound Halves

Participant milestones

Participant milestones
Measure	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 Embrace Scar Therapy Device: 16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.	Standard of Care Another 1/2 of cutaneous wound will be treated per standard of care Standard of Care: Without the embrace Scar Therapy Device
Overall Study STARTED	49 49	49 49
Overall Study COMPLETED	20 20	20 20
Overall Study NOT COMPLETED	29 29	29 29

Reasons for withdrawal

Reasons for withdrawal
Measure	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 Embrace Scar Therapy Device: 16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.	Standard of Care Another 1/2 of cutaneous wound will be treated per standard of care Standard of Care: Without the embrace Scar Therapy Device
Overall Study Withdrawal by Subject	14	14
Overall Study Lost to Follow-up	15	15

Baseline Characteristics

Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 3 months

Population: The study was terminated early due to inadequate participant follow-up during the COVID-19 pandemic, resulting in the analysis of only 20 participants. Each patient's wound was divided into two sides, labeled A and B. An intervention was randomly assigned to each side, leading to a total of 40 wound halves analyzed. However, due to the limited sample size, no conclusive results can be drawn.

Outcome measures

Outcome measures
Measure	Embrace Scar Therapy Device n=20 wound halves 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 Embrace Scar Therapy Device: 16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.	Standard of Care n=20 wound halves Another 1/2 of cutaneous wound will be treated per standard of care Standard of Care: Without the embrace Scar Therapy Device
Physician Observer Scar Assessment Score (POSAS)	20.45 score on a scale Standard Deviation 5.46	19.28 score on a scale Standard Deviation 6.84

PRIMARY outcome

Timeframe: 3 months

The width of the scar on both sides will also be measured and recorded 1 cm from midline on both sides of the scar

Outcome measures

Outcome measures
Measure	Embrace Scar Therapy Device n=20 wound halves 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 Embrace Scar Therapy Device: 16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.	Standard of Care n=20 wound halves Another 1/2 of cutaneous wound will be treated per standard of care Standard of Care: Without the embrace Scar Therapy Device
Width of the Scar	1.62 mm Standard Deviation 2.40	1.40 mm Standard Deviation 2.31

Adverse Events

Embrace Scar Therapy Device

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Embrace Scar Therapy Device n=49 participants at risk 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 Embrace Scar Therapy Device: 16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.	Standard of Care n=49 participants at risk Another 1/2 of cutaneous wound will be treated per standard of care Standard of Care: Without the embrace Scar Therapy Device
Skin and subcutaneous tissue disorders Adhesive Reaction	18.4% 9/49 • Baseline Visit (Day 0) to Follow Up Visit (3 Months) The data collection process for the study included a complication form designed to document all adverse events experienced by participants. The form required detailed information regarding the timing of the complications, the affected side, and any relevant contextual notes. Participants were invited to contact the research team at any time to report AEs. Furthermore, during the three-month follow-up, patients were asked about complication, and the reviewer noted any complications they observed.	10.2% 5/49 • Baseline Visit (Day 0) to Follow Up Visit (3 Months) The data collection process for the study included a complication form designed to document all adverse events experienced by participants. The form required detailed information regarding the timing of the complications, the affected side, and any relevant contextual notes. Participants were invited to contact the research team at any time to report AEs. Furthermore, during the three-month follow-up, patients were asked about complication, and the reviewer noted any complications they observed.
Skin and subcutaneous tissue disorders Suture Abscess	2.0% 1/49 • Baseline Visit (Day 0) to Follow Up Visit (3 Months) The data collection process for the study included a complication form designed to document all adverse events experienced by participants. The form required detailed information regarding the timing of the complications, the affected side, and any relevant contextual notes. Participants were invited to contact the research team at any time to report AEs. Furthermore, during the three-month follow-up, patients were asked about complication, and the reviewer noted any complications they observed.	0.00% 0/49 • Baseline Visit (Day 0) to Follow Up Visit (3 Months) The data collection process for the study included a complication form designed to document all adverse events experienced by participants. The form required detailed information regarding the timing of the complications, the affected side, and any relevant contextual notes. Participants were invited to contact the research team at any time to report AEs. Furthermore, during the three-month follow-up, patients were asked about complication, and the reviewer noted any complications they observed.
Skin and subcutaneous tissue disorders Infection	6.1% 3/49 • Baseline Visit (Day 0) to Follow Up Visit (3 Months) The data collection process for the study included a complication form designed to document all adverse events experienced by participants. The form required detailed information regarding the timing of the complications, the affected side, and any relevant contextual notes. Participants were invited to contact the research team at any time to report AEs. Furthermore, during the three-month follow-up, patients were asked about complication, and the reviewer noted any complications they observed.	4.1% 2/49 • Baseline Visit (Day 0) to Follow Up Visit (3 Months) The data collection process for the study included a complication form designed to document all adverse events experienced by participants. The form required detailed information regarding the timing of the complications, the affected side, and any relevant contextual notes. Participants were invited to contact the research team at any time to report AEs. Furthermore, during the three-month follow-up, patients were asked about complication, and the reviewer noted any complications they observed.
Skin and subcutaneous tissue disorders Localized Pain at Site	2.0% 1/49 • Baseline Visit (Day 0) to Follow Up Visit (3 Months) The data collection process for the study included a complication form designed to document all adverse events experienced by participants. The form required detailed information regarding the timing of the complications, the affected side, and any relevant contextual notes. Participants were invited to contact the research team at any time to report AEs. Furthermore, during the three-month follow-up, patients were asked about complication, and the reviewer noted any complications they observed.	0.00% 0/49 • Baseline Visit (Day 0) to Follow Up Visit (3 Months) The data collection process for the study included a complication form designed to document all adverse events experienced by participants. The form required detailed information regarding the timing of the complications, the affected side, and any relevant contextual notes. Participants were invited to contact the research team at any time to report AEs. Furthermore, during the three-month follow-up, patients were asked about complication, and the reviewer noted any complications they observed.
Skin and subcutaneous tissue disorders Dehiscence	2.0% 1/49 • Baseline Visit (Day 0) to Follow Up Visit (3 Months) The data collection process for the study included a complication form designed to document all adverse events experienced by participants. The form required detailed information regarding the timing of the complications, the affected side, and any relevant contextual notes. Participants were invited to contact the research team at any time to report AEs. Furthermore, during the three-month follow-up, patients were asked about complication, and the reviewer noted any complications they observed.	2.0% 1/49 • Baseline Visit (Day 0) to Follow Up Visit (3 Months) The data collection process for the study included a complication form designed to document all adverse events experienced by participants. The form required detailed information regarding the timing of the complications, the affected side, and any relevant contextual notes. Participants were invited to contact the research team at any time to report AEs. Furthermore, during the three-month follow-up, patients were asked about complication, and the reviewer noted any complications they observed.

Additional Information

Dr. Daniel Eisen

UC Davis - Department of Dermatology

Phone: 916-551-2611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Embrace Scar Therapy Device n=49 Wound Halves 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 Embrace Scar Therapy Device: 16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.	Standard of Care n=49 Wound Halves Another 1/2 of cutaneous wound will be treated per standard of care Standard of Care: Without the embrace Scar Therapy Device	Total n=98 Wound Halves Total of all reporting groups
Age, Categorical <=18 years	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Age, Categorical Between 18 and 65 years	24 Wound Halves n=49 Wound Halves	24 Wound Halves n=49 Wound Halves	48 Wound Halves n=98 Wound Halves
Age, Categorical >=65 years	25 Wound Halves n=49 Wound Halves	25 Wound Halves n=49 Wound Halves	50 Wound Halves n=98 Wound Halves
Age, Continuous	61.55 years STANDARD_DEVIATION 15.16 • n=49 Wound Halves	61.55 years STANDARD_DEVIATION 15.16 • n=49 Wound Halves	61.55 years STANDARD_DEVIATION 15.16 • n=98 Wound Halves
Sex: Female, Male Female	26 Wound Halves n=49 Wound Halves	26 Wound Halves n=49 Wound Halves	52 Wound Halves n=98 Wound Halves
Sex: Female, Male Male	23 Wound Halves n=49 Wound Halves	23 Wound Halves n=49 Wound Halves	46 Wound Halves n=98 Wound Halves
Race (NIH/OMB) American Indian or Alaska Native	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Race (NIH/OMB) Asian	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Race (NIH/OMB) Black or African American	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Race (NIH/OMB) White	47 Wound Halves n=49 Wound Halves	47 Wound Halves n=49 Wound Halves	94 Wound Halves n=98 Wound Halves
Race (NIH/OMB) More than one race	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Race (NIH/OMB) Unknown or Not Reported	2 Wound Halves n=49 Wound Halves	2 Wound Halves n=49 Wound Halves	4 Wound Halves n=98 Wound Halves
Region of Enrollment United States	49 Wound Halves n=49 Wound Halves	49 Wound Halves n=49 Wound Halves	98 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Cheek	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Chin	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Eyelids	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Forehead	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Lip	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Neck	1 Wound Halves n=49 Wound Halves	1 Wound Halves n=49 Wound Halves	2 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Preauricular	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Post-auricular	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Temple	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Scalp	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=49 Wound Halves	0 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Chest	9 Wound Halves n=49 Wound Halves	9 Wound Halves n=49 Wound Halves	18 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Shoulder	3 Wound Halves n=49 Wound Halves	3 Wound Halves n=49 Wound Halves	6 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Back	14 Wound Halves n=49 Wound Halves	14 Wound Halves n=49 Wound Halves	28 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Abdomen	3 Wound Halves n=49 Wound Halves	3 Wound Halves n=49 Wound Halves	6 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Arm	14 Wound Halves n=49 Wound Halves	14 Wound Halves n=49 Wound Halves	28 Wound Halves n=98 Wound Halves
Location of Surgical Procedure Leg	5 Wound Halves n=49 Wound Halves	5 Wound Halves n=49 Wound Halves	10 Wound Halves n=98 Wound Halves
Surgeon Experience Fellow	3 Wound Halves n=49 Wound Halves	3 Wound Halves n=49 Wound Halves	6 Wound Halves n=98 Wound Halves
Surgeon Experience Attending	28 Wound Halves n=49 Wound Halves	28 Wound Halves n=49 Wound Halves	56 Wound Halves n=98 Wound Halves
Surgeon Experience Resident	18 Wound Halves n=49 Wound Halves	18 Wound Halves n=49 Wound Halves	36 Wound Halves n=98 Wound Halves
Indication for Surgery Mohs Surgery	8 Wound Halves n=49 Wound Halves	8 Wound Halves n=49 Wound Halves	16 Wound Halves n=98 Wound Halves
Indication for Surgery Excision Surgery	41 Wound Halves n=49 Wound Halves	41 Wound Halves n=49 Wound Halves	82 Wound Halves n=98 Wound Halves