Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/23/2018 |
| Start Date: | March 15, 2017 |
| End Date: | March 2028 |
| Contact: | Daniel B Eisen, MD |
| Email: | dbeisen@ucdavis.edu |
| Phone: | (916)734-6479 |
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.
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.
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.
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
We found this trial at
1
site
Sacramento, California 95816
Phone: 916-734-6479
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