A Randomized Controlled Trial of the embrace Advanced Scar Therapy Device to Reduce Incisional Scar Formation

Abstract

Background Scarring represents a significant biomedical burden in clinical medicine. 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. Methods The authors conducted a 12-month, prospective, open-label, randomized, multicenter clinical trial to evaluate abdominoplasty scar appearance following postoperative treatment with the embrace Advanced Scar Therapy device to reduce mechanical forces on healing surgical incisions. 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. The primary endpoint for this study was the difference between assessments of scar appearance for the treated and control sides using the visual analogue scale scar score. Results Final 12-month study photographs were obtained from 36 subjects who completed at least 5 weeks of dressing application. The mean visual analogue scale score for embrace-treated scars (2.90) was significantly improved compared with control-treated scars (3.29) at 12 months (difference, 0.39; 95 percent confidence interval, 0.14 to 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 = 0.02 and p < 0.001, respectively). No serious adverse events were reported. Conclusions These results demonstrate that the embrace device significantly reduces scarring following abdominoplasty surgery. To the authors’ knowledge, this represents the first level I evidence for postoperative scar reduction.

Fibromodulin Is Essential for Fetal-Type Scarless Cutaneous Wound Healing

“…are also officers of Scarless Laboratories, Inc. ratio of type III to type I collagen. 3,9 However, Phase 3 human clinical trials with recombinant human TGF-b3 (avotermin; Juvista, Renovo, Manchester, UK) 10 and three Phase 2 studies with IL-10 failed to show efficacy in scar reduction. 11,12 In an effort to better identify key factors in scarless fetaltype repair, we used a fetal rat skin model that transitions from fetal-type scarless healing to adult-type repair with scar between embryonic days 16.5 (E16; early gestation) and 18.5 (E18; late gestation) (term, 21.5 days).…”

Mechanical Forces in Cutaneous Wound Healing: Emerging Therapies to Minimize Scar Formation

“…The Embrace device significantly improved scar appearance ( p = 0.027) according to visual analogue scale scores. 111 Using the Patient and Observer Scar Assessment Scale, both subjects and investigators concluded that Embrace treated scars displayed a significantly improved appearance ( p = 0.02 and p < 0.001, respectively). 111 As each patient served as their own control, the rate at which subjects exited the study likely had little effect on the final outcome.…”

“…111 Using the Patient and Observer Scar Assessment Scale, both subjects and investigators concluded that Embrace treated scars displayed a significantly improved appearance ( p = 0.02 and p < 0.001, respectively). 111 As each patient served as their own control, the rate at which subjects exited the study likely had little effect on the final outcome. However, these results could be skewed if the 11 subjects who did not complete the required 12-month follow-up did so because they did not believe that the Embrace device improved scar appearance.…”

“…2,109 In the pivotal (Phase III) randomized clinical trial, Embrace reduced scarring in abdominoplasty incisions. 111 Of the 67 subjects enrolled, 36 completed the 12-month study and were included in the final analysis (two patients were exited before treatment due to body mass index out of range or missing the treatment window; 13 withdrew early due to irritation or rash, one due to a wound-site infection, and four for miscellaneous reasons; 11 subjects completed treatment but did not complete the required 12-month follow-up). Four to 8 days after abdominoplasty surgery, one half of the subject's wound was treated (randomized) with the Embrace device and the other half was treated (randomized) with the operating physician's optimal treatment method.…”

Emerging Therapies for Scar Prevention

“…There are an estimated 12 million traumatic lacerations treated in the United States emergency rooms each year, 250 million surgical incisions created worldwide every year, and 11 million burns severe enough to warrant medical treatment worldwide. 1,2 In this review, an overview of both established technologies and emerging therapies for scar prevention and management are presented.…”