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Reply: tension shielding with the embrace device: does it really improve scars?

Reply: Tension Shielding with the embrace Device: Does It Really Improve Scars? Sir: We are grateful to Dr. Swanson for his thoughtful comments. We are gratified that Dr. Swanson believes that decreasing scar formation is an “extraordinary claim” and that the “implications are mind-boggling.” We are confident that the body of published scientific and clinical work supporting mechanomodulation as a safe and effective approach to decrease scar formation easily meets the bar as “extraordinary evidence.” We wholeheartedly agree with the concept of “science before marketing.” We would respectfully point out that the embrace device (Neodyne Biosciences, Inc., Menlo Park, Calif.) represents the culmination of a 20-year journey to develop scientifically based and clinically validated technologies to improve scars. This work began with the earliest human fetal surgery experience1 and initial observation of scarless fetal wound healing,2–21 extended across adult wound healing, including smalland large-animal models,22–30 and has been subjected to three clinical trials.31–33 It has been funded by grants from the National Institutes of Health, the U.S. Department of Defense, and numerous private foundations. It has been conducted at the leading academic medical centers in the world and has been published in the highest impact scientific and surgical journals, including Nature (impact factor, 38), Science (impact factor, 31), The New England Journal of Medicine (impact factor, 51), Nature Medicine (impact factor, 24), Annals of Surgery (impact factor, 6) and, of course, Plastic and Reconstructive Surgery (impact factor, 3). Possibly, even a cursory read of this substantial literature will convince Dr. Swanson that a lot of science was performed before marketing was even a glimmer in our eyes. Dr. Swanson raises concerns about the small sample size (10 patients) and our use of photographs for analysis of the scars. The analysis was performed by three board-certified plastic surgeons evaluating the photographs in a blinded fashion. Despite our sample size of 10 patients, the observed “difference” between the half of the revised scar treated with the embrace device versus the control-treated side was highly significant (p < 0.005). Dr. Swanson also had concerns with the scar revisions performed at different anatomical sites. Scars occur all over the body and, thus, the embrace device was tested on scars in several locations. Dr. Swanson also stated that “primary abdominoplasties would have provided a similar amount of tissue removal and similar tension from the same part of the body with symmetrical scars—ideal for side-by-side comparisons.” What Dr. Swanson could not have known is that we have performed a soon-to-be-published randomized controlled trial on primary abdominoplasties33: one side was treated with the embrace device, and the other side received the therapy that worked best in the experience of the treating surgeons. The results were again highly significant in favor of the embrace device. Furthermore, the difference in favor of the embracetreated side was more significant at 1 year than it was near the end of the treatment, demonstrating that the results were durable. The article describing this randomized controlled trial has recently been accepted for publication by Plastic and Reconstructive Surgery. Dr. Swanson also voiced concerns that “Patients seeking scar revisions are a selected patient group (obviously not good scar formers) that may not be comparable to first-time surgical patients.” The concerns raised about scar revisions are precisely the reasons we conducted this study. Whether or not these patients are considered “obviously not good scar-formers” is not the issue. The issue is whether a revision followed DISCLOSURE The author has no financial interest in any of the products or devices mentioned in this communication. The author has no conflicts of interest to disclose. There was no outside funding for this study.