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
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
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.
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
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