#Embrace scar therapy trial#

For hypertrophic scars, the use of tapes as a therapy to reduce the mechanical forces that stimulate excessive and long-term scarring is yet to be evaluated. Tapes have been used to aid fresh wound closure. To our knowledge, this represents the first level one evidence for post-operative scar reduction. These results demonstrate that the embrace device significantly reduces scarring following abdominoplasty surgery. Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at 12 months using the Patient and Observer Scar Assessment Scale (POSAS) evaluation (p = 0.02 and p < 0.001, respectively). The mean VAS score for embrace-treated scars (2.90) was significantly improved compared to control-treated scars (3.29) at 12 months (difference = 0.39, 95% confidence interval, p = 0.027). The primary endpoint for this study was the difference between assessments of the scar appearance for the treated and control sides using the Visual Analogue Scale (VAS) scar score.įinal twelve month study photos were obtained from 36 subjects who completed at least five weeks of dressing application. Incisions from 65 healthy adult subjects were randomized to receive embrace treatment on one half of an abdominoplasty incision and control treatment (surgeon's optimal care methods) on the other half.

#Embrace scar therapy trial#

We conducted a twelve month, prospective, open label, randomized, multi-center clinical trial to evaluate abdominoplasty scar appearance following post-operative treatment with the embrace device to reduce mechanical forces on healing surgical incisions.

Mechanomodulation has been linked to scarring through inflammation, but until now a systematic approach to attenuate mechanical force and reduce scarring has not been possible. Scarring represents a significant biomedical burden in clinical medicine.