A Randomized Controlled Trial of the EmbraceŽ Device to Reduce Incisional Scar Formation

Goals/Purpose: Scarring represents a significant biomedical burden in clinical medicine. Off-loading tension across a healing wound has been shown in animal studies to reduce scarring, but until now a systematic approach to attenuate mechanical force and reduce scarring in humans has not been possible.

Methods/Technique: A twelve month, prospective, open label, randomized, multi-center clinical trial was undertaken with 65 subjects who had undergone a de novo abdominoplasty.  The embrace® dressing, which actively managed the mechanical tension around a healing incision line, was applied to half of the incision and the remainder of the incision was treated per each physician’s optimal standard of care.  The primary endpoint for this study was the difference between blinded independent scores of scar appearance for the treated and control sides using the Visual Analogue Scale scar score. Secondary endpoints included comparative scar assessments by the treating physician and subjects using the Patient and Observer Scar Assessment Scale (POSAS).

Results/Complications: The mean Visual Analogue Scale 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 [0.14, 0.66], p = 0.027). 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 evaluation (p = 0.010 and p < 0.001, respectively).

Conclusion: These results demonstrate that the embrace device significantly reduces scarring following abdominoplasty surgery.