Linear Cutaneous WoundNCT03294863
Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure
A study testing Embrace Scar Therapy Device in people with Linear Cutaneous Wound, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Linear Cutaneous Wound
- What is being tested?
- Embrace Scar Therapy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2017to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis, Department of Dermatology
Sacramento, California, 95816
About this study
Official title: 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.
Read the 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.
- Conditions
- Linear Cutaneous Wound
- Being tested
- Embrace Scar Therapy Device, Standard of Care
- Keywords
- Scar, Cosmesis, Embrace Device, Split Wound, Wound Closure, Cutaneous Wound
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embrace Scar Therapy DeviceDevice
16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.
Standard of CareOther
Without the embrace Scar Therapy Device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Embrace Scar Therapy Device |
| Standard of Care | Placebo comparator | Another 1/2 of cutaneous wound will be treated per standard of care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start15 Mar 2017
- Primary completion1 Dec 2021
- Study completion8 Dec 2025
Why it stopped: poor patient follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Linear Cutaneous WoundStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Each subject receives both types of interventions upon the same scar in order for comparison.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel B Eisen, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294863
- Sponsor's protocol ID
- 101077
- Status last verified
- Jun 2026
- First submitted
- 22 Sep 2017
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Embrace Device After Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT03294863
- Acronym / sponsor ID
- 101077
- Conditions
- Linear Cutaneous Wound
- Keywords
- Scar, Cosmesis, Embrace Device, Split Wound, Wound Closure, Cutaneous Wound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor patient follow-up
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Posted 10 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each subject receives both types of interventions upon the same scar in order for comparison.
| Arm | Type | Receives |
|---|---|---|
| Embrace Scar Therapy Device | Experimental | Device: Embrace Scar Therapy Device16x5-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 |
| Standard of Care | Placebo comparator | Other: Standard of CareAnother 1/2 of cutaneous wound will be treated per standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Mentally handicapped
- Unable to understand written and oral English
- Incarceration
- Under 18 years of age
- Pregnant Women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embrace Scar Therapy Device16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive. | Device | Embrace Scar Therapy Device |
| Standard of CareWithout the embrace Scar Therapy Device | Other | Standard of Care |
Primary outcome
Physician Observer Scar Assessment Score (POSAS)
Time frame: 3 months
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.
Width of the Scar
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Linear Cutaneous Wound
Active, not recruiting
Influence of Sun Protection and Linear Repair of Cutaneous Surgical Defects
Surgical Wound, Wound Heal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B Eisen, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embrace Scar Therapy Device in people with Linear Cutaneous Wound, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Observer Scar Assessment Score (POSAS) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.