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Tension Shielding with the embrace Device

Does It Really Improve Scars?

Gurtner, Geoffrey C. M.D.; Longaker, Michael T. M.D., M.B.A.

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Plastic and Reconstructive Surgery: October 2014 - Volume 134 - Issue 4 - p 664e-666e
doi: 10.1097/PRS.0000000000000560
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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 small- and 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 embrace-treated 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 by embrace treatment can improve the scar compared with current solutions. Our data strongly support that this is true.

As to the perception of commercial bias, we would respectfully point out that there is no such thing as a free lunch. The United States currently operates under a capitalist economic system, meaning that for most endeavors, a profit motive must exist for activity to occur. To bring a novel technology from “bench to bedside” in a safe and ethical manner in the United States is an expensive proposition, even for a device as seemingly straightforward as the embrace dressing. Unlike the basic scientific discovery described above, there are no grants or funding mechanisms to support activities such as obtaining U.S. Food and Drug Administration clearance, setting up high-quality U.S. manufacturing, and establishing a distribution channel. In a capitalist economy, one must reach out to the private sector to find investors to support these expenses. In return, these investors expect some incremental return on their invested capital, which requires commercialization and sales. For better or worse, this is how innovation works in a capitalist economy. There is no question that alternative utopian systems exist that avoid the profit motive, but we would contend that the twentieth century experience with such experimental systems is not encouraging.

As Dr. Swanson rightly points out, this potentially creates “conflicts of interest” and, potentially, commercial bias. The way that these sorts of conflicts are handled in an ethical manner is through complete and transparent disclosure of all potential conflicts. Despite the insinuations by Dr. Swanson, all authors provided a thorough and complete disclosure in complete compliance with the policies of Plastic and Reconstructive Surgery. Nothing was hidden or buried, and much of what Dr. Swanson is concerned about is a matter of semantics. This is important because the authors’ thorough and complete disclosure provided third-party peer reviewers an opportunity to make an independent determination of any potential commercial bias and ask for changes or reject the manuscript. In this case, our manuscript passed this impartial peer review and the data were felt to be compelling enough for publication. Although Dr. Swanson may not agree with the outcome, in this case, the system worked as designed to manage potential conflicts of interest. No amount of editorial tilting at windmills will change this fact.

More philosophically, we believe that this type of misunderstanding regarding innovation and conflict of interest is not helpful for the specialty of plastic surgery. Conflicts of interest and potential financial biases exist almost everywhere in the practice of medicine. In the current fee-for-service model, there are financial incentives to perform cases faster (to perform more cases), to treat patients insured by private payers rather than Medicaid, and to perform procedures with preferential (i.e., carved out) payments. None of these are strictly aligned with the best interests of patients. To focus exclusively on one source of conflict (commercial) while turning a blind eye to all the others strikes us as shortsighted and naive. We believe that neither the patient nor society is well served by divorcing practicing physicians from the innovation process through regulation or opprobrium.

DISCLOSURE

Dr. Gurtner and Dr. Longaker 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.

Geoffrey C. Gurtner, M.D.

Michael T. Longaker, M.D., M.B.A.

Department of Surgery

Stanford University School of Medicine

Stanford, Calif.

[email protected]

REFERENCES

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2. Longaker MT, Harrison MR, Crombleholme TM, et al. Studies in fetal wound healing: I. A factor in fetal serum that stimulates deposition of hyaluronic acid. J Pediatr Surg. 1989;24:789–792
3. Longaker MT, Harrison MR, Langer JC, et al. Studies in fetal wound healing: II. A fetal environment accelerates fibroblast migration in vitro. J Pediatr Surg. 1989;24:793–797; discussion 798
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31. Gurtner GC, Dauskardt RH, Wong VW, et al. Improving cutaneous scar formation by controlling the mechanical environment: Large animal and phase I studies. Ann Surg. 2011;254:217–225
32. Lim AF, Weintraub J, Kaplan EN, et al. The embrace device significantly decreases scarring following scar revision surgery in a randomized controlled trial. Plast Reconstr Surg. 2014;133:398–405
33. Longaker MT, Rohrich RJ, Greenberg L, et al. A randomized controlled trial of the embrace device to reduce incisional scar formation. Plast Reconstr Surg. Accepted for publication

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