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

Longaker, Michael T. M.D., M.B.A.; Rohrich, Rod J. M.D.; Greenberg, Lauren M.D.; Furnas, Heather M.D.; Wald, Robert M.D.; Bansal, Vivek M.D.; Seify, Hisham M.D.; Tran, Anthony M.D.; Weston, Jane M.D.; Korman, Joshua M. M.D.; Chan, Rodney M.D.; Kaufman, David M.D.; Dev, Vipul R. M.D.; Mele, Joseph A. M.D.; Januszyk, Michael M.D.; Cowley, Christy M.P.H.; McLaughlin, Peggy B.S.; Beasley, Bill B.S.; Gurtner, Geoffrey C. M.D.

Plastic and Reconstructive Surgery: September 2014 - Volume 134 - Issue 3 - p 536–546
doi: 10.1097/PRS.0000000000000417
Reconstructive: Trunk: Original Articles

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.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Stanford, Santa Rosa, Fullerton, Danville, Newport Beach, Atherton, Mountain View, Folsom, Bakersfield, Walnut Creek, and Menlo Park, Calif.; and Dallas, Arlington, and San Antonio, Texas

From the Department of Surgery, Division of Plastic and Reconstructive Surgery, Stanford University School of Medicine; Plastic Surgery Associates; The Aesthetic Institute; Elite MD, Inc.; Newport Plastic & Reconstructive Surgery Associates; Atherton Plastic Surgery; Korman Plastic Surgery; Kaufman & Clark Plastic Surgery; VIP DEV MD; Walnut Creek Plastic Surgery; Neodyne Bioscience, Inc.; the Department of Plastic Surgery, University of Texas Southwestern Medical Center, Arlington Plastic Surgery; and Clinical Division and Burn Center, United States Army Institute of Surgical Research.

Received for publication December 3, 2013; accepted March 10, 2014.

This trial is registered under the name “A Study of a Novel Silicone Dressing to Minimize Scar Formation (REFINE),” ClinicalTrials.gov identification number NCT01399099 (http://clinicaltrials.gov/show/NCT01399099).

Disclosure: Michael T. Longaker, M.D., M.B.A., and Geoffrey C. Gurtner, M.D., are founders of, have equity positions in, and serve on the board of Neodyne Biosciences, Inc., which provided the devices used in the study and supported the clinical trial, and Bill Beasley, B.S., is an employee and officer of the company. Christy Cowley, M.P.H., and Peggy McLaughlin, B.S., are consultants to Neodyne Biosciences, Inc., and have equity positions in the company. Rod J. Rohrich, M.D., Lauren Greenberg, M.D., Heather Furnas, M.D., Robert Wald, M.D., Vivek Bansal, M.D., Hisham Seify, M.D., Anthony Tran, M.D., Jane Weston, M.D., Joshua M. Korman, M.D., Rodney Chan, M.D., David Kaufman, M.D., Vipul R. Dev, M.D., and Joseph A. Mele, M.D., received clinical research grant support for participation in the study. Michael T. Longaker, M.D., M.B.A., analyzed the data and wrote this article while on sabbatical from Stanford University. Rod J. Rohrich, M.D., received clinical research grant support for participation in the study; he also receives instrument royalties from Micrins Instruments and book royalties from Quality Medical Publishing.

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Michael T. Longaker, M.D., M.B.A., Division of Plastic and Reconstructive Surgery, Department of Surgery, Stanford University, Hagey Laboratory for Pediatric Regenerative Medicine, 257 Campus Drive West, Stanford, Calif. 94305-5148, longaker@stanford.edu

Geoffrey C. Gurtner, M.D., Division of Plastic and Reconstructive Surgery, Department of Surgery, Stanford University, Hagey Laboratory for Pediatric Regenerative Medicine, 257 Campus Drive West, Stanford, Calif. 94305-5148, ggurtner@stanford.edu

©2014American Society of Plastic Surgeons