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The embrace Device Significantly Decreases Scarring following Scar Revision Surgery in a Randomized Controlled Trial

Lim, Angeline F. M.D.; Weintraub, Jennifer M.D.; Kaplan, Ernest N. M.D.; Januszyk, Michael M.D.; Cowley, Christy M.P.H.; McLaughlin, Peggy B.S.; Beasley, Bill B.S.; Gurtner, Geoffrey C. M.D.; Longaker, Michael T. M.D., M.B.A.

Plastic & Reconstructive Surgery: February 2014 - Volume 133 - Issue 2 - p 398–405
doi: 10.1097/01.prs.0000436526.64046.d0
Reconstructive: Trunk: Original Articles
Discussion

Background: Mechanically offloading or shielding an incision significantly reduces scarring in both animal and first-in-human studies. Whether or not this strategy would be effective following scar revision surgery was previously unknown. In this article, the authors report that the embrace device, which uses principles of mechanomodulation, significantly improves aesthetic outcomes following scar revision surgery.

Methods: A prospective, open-label, randomized, single-center study was conducted to evaluate the appearance of scars following revision and embrace treatment. Revision surgery was performed on 12 patients, each acting as his or her own control, and outcomes were assessed at 6 months. A visual analogue scale was used to evaluate each scar, rated by four independent surgeons who were not involved in the study.

Results: Evaluation of 6-month scar images by four independent surgeons using the visual analogue scale demonstrated a highly significant improvement in scar appearance following embrace treatment (p < 0.005).

Conclusion: The embrace device represents a powerful new technology for significantly improving scar appearance following revision surgery.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Palo Alto, Stanford, and Menlo Park, Calif.

From the Duet Plastic Surgery Clinic; the Department of Surgery, Division of Plastic and Reconstructive Surgery, Stanford University School of Medicine; and Neodyne Biosciences, Inc.

Received for publication May 17, 2013; accepted July 12, 2013.

This trial is registered under the name “Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE),” Clinical Trials.gov identification number NCT01430130 (http://clinicaltrials.gov/show/NCT01430130).

Disclosure: Michael T. Longaker, M.D., M.B.A., and Geoffrey C. Gurtner, M.D., have equity in Neodyne Biosciences, Inc., which provided the devices used in the study and supported the clinical trial. Christy Cowley, M.P.H., Peggy McLaughlin, B.S., and Bill Beasley, B.S., are consultants to, or employed by, Neodyne Biosciences, Inc., and have equity positions in the company. Dr. Longaker analyzed the data and wrote this article while on sabbatical from Stanford University.

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

©2014American Society of Plastic Surgeons