Drs. Lim et al.1 claim that the embrace device (Neodyne Biosciences, Inc., Menlo Park, Calif.) significantly decreases scarring. If true, this product represents a monumental advance. As the authors note,1 no previous treatment has been proven effective in minimizing scars. Is it time for all plastic surgeons to order this product?
Although the study has a high-level design, methodologic considerations merit scrutiny.2 The investigators did not evaluate consecutive patients. There is no reported inclusion rate. These deficiencies invite selection bias.2 The authors concede that their patient volume, only 10 patients who completed the study, is “relatively small.”1
The measuring device was qualitative. Photographic measurements of scar dimensions might have been helpful. It is risky to dismiss objective measures by saying that in the end it is the patient’s opinion that matters.1 It is hoped that we aspire to a real benefit and not just a perceived one. “Tension-shielding”1 sounds desirable. It would be useful for the authors to demonstrate that their device really does minimize wound tension. Other investigators3 have used a tensiometer to measure skin response to surface tension.
There are problems with the figure legends. The legends to Figures 3, 4, and 5 all state that the above, left photographs represent preoperative photographs and the remaining photographs are all taken after revision.1 However, the appearance of the scars and adjacent skin markings reveal that the photographs depict the same scar.
If only 10 patients are being evaluated, the methodology needs to be pristine. Photographs given to a panel for evaluation must be standardized, including identical lighting and the same degree of magnification, to make the comparison a fair one. Unfortunately, this is not the case. The control scar appears wider than the embrace-treated scar in Figure 4. However, this untreated scar is also magnified much more than the embrace-treated scar, as revealed by skin markings (Fig. 1). The exposure is also darker for the control scar. In Figure 5, a pigmented skin lesion disappears in a postoperative photograph, evidently removed by means of digital editing (Fig. 2). Inaccurate figure legends, nonstandardized photographs, and digital editing of photographs all detract from the credibility of the images.
Apart from photographic inconsistencies, there are other confounders. The authors studied scars at different anatomical sites. Three surgeons performed the surgery using three suturing techniques. Treatment of the control side was variable. It would have been preferable to treat the control side with a noncontracting silicone gel sheet to rule out any possible effects of a silicone gel dressing, which some investigators claim is helpful for scars in itself.4
In the referenced experimental study,5 nine abdominoplasty patients were evaluated. Why did the authors choose scar revisions for this clinical follow-up study (that was supposed to include a larger number of patients)?5 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.5 Patients seeking scar revisions are a select patient group (obviously not good scar-formers) that may not be comparable to first-time surgical patients. Such scars may not be symmetrical. Previous surgery and scarring over different body sites introduce other variables that may affect the analysis.
This device is supposed to work by displacing wound tension to the surrounding skin, isolating the wound from tension.1 However, the surrounding skin tension is likely to relax quickly. It is not clear from this study whether this device can maintain a tension-free wound for any length of time. Skin exhibits a high degree of stress relaxation (i.e., stress is relieved quickly when stretched),6 a phenomenon that occurs within minutes.3 Scar maturation and remodeling occur over a period of months, up to 1 year.7 Patients are unlikely to be compliant with a device that must be worn for extended periods. It is unknown how patient movement affects the device. The financial considerations for a product that is replaced each week are relevant.
The most serious problem with this study is commercial bias. Five authors are also investors. Dr. Long aker is the senior and corresponding author. The disclosure paragraph1 states that he has equity in the sponsoring company, but he is more than just an investor. He is also the Chairman of the Board and Founder of Neodyne Biosciences, Inc.8 According to the company Web site,8 he started this company in 2007, before the scientific studies supporting the method1,5 were conducted. Another study author, Bill Beasley, is listed in the disclosure as either a consultant or employee of the company.1 In fact, he is the company president.8 It is one thing to be a passive investor; it is quite another to be an officer of a company with a fiduciary responsibility. The company Web site9 advertises no other product. It appears that its economic viability is entirely reliant on this device. Failure (to find treatment efficacy) is not an option. Already, this product is advertised to minimize scars after common procedures such as breast augmentations and tummy tucks.10
Alas, scar formation is a complicated problem,7 unlikely to be solved with a simple fix. We are reminded of the importance of “science before marketing.” Only by following the scientific method2 can we expect to avoid adopting unsound treatments. A method that decreases scar formation is an extraordinary claim. If true, virtually all scars would benefit from this treatment. The commercial implications are mind-boggling. However, as Carl Sagan put it,11 “Extraordinary claims require extraordinary evidence.” The evidence presented here does not meet this bar.
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.
Eric Swanson, M.D.
11413 Ash Street
Leawood, Kan. 66211
1. 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
2. Swanson E. Levels of evidence in cosmetic surgery: Analysis and recommendations using a new CLEAR classification. Plast Reconstr Surg Glob Open. 2013;1:e66
3. Saulis AS, Lautenschlager EP, Mustoe TA. Biomechanical and viscoelastic properties of skin, SMAS, and composite flaps as they pertain to rhytidectomy. Plast Reconstr Surg. 2002;110:590–598; discussion 599
4. Akaishi S, Akimoto M, Hyakusoku H, Ogawa R. The tensile reduction effects of silicone gel sheeting. Plast Reconstr Surg. 2010;126:109e–111e
5. 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
6. Gibson T, Kenedi RM. Biomechanical properties of the skin. Surg Clin North Am. 1967;47:279–294
7. Broughton G II, Janis JE, Attinger CE. Wound healing: The basic science of wound healing. Plast Reconstr Surg. 2006;117(7 Suppl):12S–34S
8. Neodyne Biosciences. . . Neodyne Biosciences Announces the Addition of Two New Members to the Board of Directors to Oversee the Strategic Launch of First Commercially Available Product. Available at: http://www.neodynebio.com/press/new_board_member_announcement_final.pdf
. Accessed February 18, 2014
9. Neodyne Biosciences. Neodyne Biosciences. Available at: http://www.neodynebio.com/index.html
. Accessed February 18, 2014
10. Neodyne Biosciences. Embrace Advanced Scar Therapy. Available at: http://www.embracescartherapy.com/how-it-works/
. Accessed February 18, 2014
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