Plastic & Reconstructive Surgery:
Reconstructive: Trunk: Original Articles
Discussion: The embrace Device Significantly Decreases Scarring following Scar Revision Surgery in a Randomized Controlled Trial
Orgill, Dennis P. M.D., Ph.D.; Ogawa, Rei M.D., Ph.D.
Boston, Mass.; and Tokyo, Japan
From the Division of Plastic Surgery, Brigham and Women’s Hospital, Harvard Medical School; and the Department of Plastic, Reconstructive, and Aesthetic Surgery, Nippon Medical School.
Received for publication August 23, 2013; accepted September 9, 2013.
Disclosure: The authors have no financial interest to declare in relation to the content of this Discussion or of the related article.
Dennis P. Orgill, M.D., Ph.D., 75 Francis Street, Boston, Mass. 02115, email@example.com
Each day in our clinics, patients ask us questions about scars. Many incorrectly believe that plastic surgeons can close incisions without scars. Even for elective procedures with a low risk of scar, a surprising number of patients ask us what they can do to minimize scarring—and to date our options for treating scars are fairly limited. Scarring appears to be a late evolutionary development that is seen in mammals but not in other life forms, such as amphibians, which regenerate after injury. Humans in particular have difficulties with scarring and can “overheal” to form hypertrophic scars and keloids. After healing, there is much more emphasis on improving aesthetic appearance and quality of life. Patients who survive liver transplantation complain about so-called “Mercedes-Benz” scars on their chest and abdomen. Keloids can be persistent and difficult for surgeons to treat.
There have been multiple advances in understanding the pathogenesis and modulating factors in cutaneous scar formation. A major breakthrough came in 1979 when it was noticed that a human fetus did not scar.1 This observation led to several remarkable scientific discoveries in the pathogenesis of postnatal human scarring, including detailed descriptions of molecular pathways responsible for scarring. High hopes were raised for the possibility for a single drug agent to directly block these pathways and reduce or prevent scarring. Despite a well–worked-out mechanism of action and successful phase I and phase II European trials,2 human recombinant transforming growth factor β3 failed the phase III trial.3 This raises the question of the best approach to treat scars that have multiple molecular pathways. A different approach would be to use some type of biophysical force that could potentially alter multiple pathways.4
Scars respond poorly to mechanical stress. Scarring in areas of movement, such as the sternum and shoulders, can be particularly problematic.5 Tension applied perpendicular to the axis of the scar induces a hypertrophic-like scar in a mouse model.6 Ingber has demonstrated that tension applied to individual cells in culture results in cell proliferation.7 Cell proliferation from mechanical forces is seen in abdominal skin during pregnancy or wound healing using suction-based wound healing devices.8 Plastic surgeons should consider mechanical forces as a therapeutic modality in much of what we do.
Lim et al. studied 12 patients who had scar revision surgery and applied their tension-reducing therapy to the wounds. They used each patient as a control, used a visual analogue scale to assess scarring by blinded observers, and followed the patients for 6 months. This is a nicely designed clinical trial that used only a small group of patients to show a statistically significant difference, qualifying it for a high level of evidence (level II). Clearly, this study raises some important questions. What happens over the long term when scars naturally get better over time? Will this difference become less apparent? What is the effectiveness of this technology in patients at high risk for keloid or hypertrophic scar formation? Do the wounds require the long treatment times used in the study? Future studies will be needed to better define how to best use this technology and for which specific scars.
Plastic surgery as a field attracts individuals who spawn innovation. Each day we see patients with challenging problems that our current technology and techniques are inadequate to address, while we think of ways to improve our results.9 The net effect of this collective innovation in our field is a constant shift in practice patterns. Think of all of the advances in microsurgery, flap design, minimally invasive techniques, wound treatment devices, and tissue grafting techniques that have greatly enriched our specialty. Few of us who have been in practice for more than 10 years are doing things the same way as when we entered practice. We have happily shared these innovations with other surgical specialties that have very often incorporated them into their practices. Innovation is challenging, particularly in the medical device space. At the end of the day, a device needs to be manufactured with a high degree of precision, must provide reliable results, must be safe and effective, and—over the long term—needs to be profitable for industry. As surgeons, we often think that coming up with the idea is the most difficult part; however, the experienced innovator realizes this may be only about less than 5 percent of the total process (Fig. 1).
Lim et al. should be congratulated for taking an idea from concept to market and doing it in a way that provides both mechanism-of-action data and a carefully designed prospective clinical trial that demonstrates efficacy. Very few plastic surgeons have been able to navigate this transition while holding to our core values of providing high-level studies to support their innovations. Part of the credit for this innovation no doubt goes to Stanford University, a pioneer in translating ideas developed in universities to successful products that are used today. Their Biodesign center brings together clinicians, engineers, business development experts, and experts in intellectual property who work together on translating ideas to products. They have set up a sensible conflict-of-interest policy that balances the needs of investigators, patients, and institutions in the translation process. We hope that what they have done will serve as a model for plastic surgery, as continued innovation is essential for the survival of our specialty.
1. Rowlatt U. Intrauterine healing in a 20-week human fetus. Virchows Arch. 1979;381:353–361
2. So K, McGrouther DA, Bush JA, et al. Avotermin for scar improvement following scar revision surgery: A randomized, double-blind, within-patient, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2011;128:163–172
4. Huang C, Holfeld J, Schaden W, Orgill D, Ogawa R. Mechanotherapy: Revisiting physical therapy and recruiting mechanobiology for a new era in medicine. Trends Mol Med. 2013;19:555–564
5. Ogawa R, Okai K, Tokumura F, et al. The relationship between skin stretching/contraction and pathologic scarring: The important role of mechanical forces in keloid generation. Wound Repair Regen. 2012;20:149–157
6. Aarabi S, Bhatt KA, Shi Y, et al. Mechanical load initiates hypertrophic scar formation through decreased cellular apoptosis. FASEB J. 2007;21:3250–3261
7. Ingber DE. The architecture of life. Sci Am. 1998;278:48–57
8. Saxena V, Hwang CW, Huang S, Eichbaum Q, Ingber D, Orgill DP. Vacuum-assisted closure: Microdeformations of wounds and cell proliferation. Plast Reconstr Surg. 2004;114:1086–1096; discussion 1097
9. Erba P, Ogawa R, Vyas R, Orgill DP. The reconstructive matrix: A new paradigm in reconstructive plastic surgery. Plast Reconstr Surg. 2010;126:492–498
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