Clinical Studies

~Mustoe, Thomas A. M.D.; Cooter, Rodney D. M.D.; Gold, Michael H. M.D.; Richard Hobbs, F. D. F.R.C.G.P.; Ramelet, Albert-Adrien M.D.; Shakespeare, Peter G. M.D.; Stella, Maurizio M.D.; Téot, Luc M.D.; Wood, Fiona M. M.D.; Ziegler, Ulrich E. M.D.for the International Advisory Panel on Scar Management.


~Plastic and Reconstructive Surgery: August 2002 - Volume 110 - Issue 2 - p 560–571.


Many techniques for the management of hypertrophic scars and keloids have been proven through extensive use, but few have been supported by prospective studies with adequate control groups. Several new therapies showed good results in small-scale trials, but these have not been repeated in larger trials with long-term follow-up. This article reports a qualitative overview of the available clinical literature by an international panel of experts using standard methods of appraisal. The article provides evidence-based recommendations on prevention and treatment of abnormal scarring and, where studies are insufficient, consensus on best practice.


The recommendations focus on the management of hypertrophic scars and keloids, and are internationally applicable in a range of clinical situations. These recommendations support a move to a more evidence-based approach in scar management. This approach highlights a primary role for silicone gel sheeting and intralesional corticosteroids in the management of a wide variety of abnormal scars. The authors concluded that these are the only treatments for which sufficient evidence exists to make evidence-based recommendations. A number of other therapies that are in common use have achieved acceptance by the authors as standard practice. However, it is highly desirable that many standard practices and new emerging therapies undergo large-scale studies with long-term follow-up before being recommended conclusively as alternative therapies for scar management. (Plast. Reconstr. Surg. 110: 560, 2002.)

~Monstrey S; Middelkoop E; Vranckx JJ; Bassetto F; Ziegler UE; Meaume S; Téot L.


~J Plast Reconstr Aesthet Surg. 2014; 67(8):1017-25 (ISSN: 1878-0539)


Hypertrophic scars and keloids can be aesthetically displeasing and lead to severe psychosocial impairment. Many invasive and non-invasive options are available for the plastic (and any other) surgeon both to prevent and to treat abnormal scar formation. Recently, an updated set of practical evidence-based guidelines for the management of hypertrophic scars and keloids was developed by an international group of 24 experts from a wide range of specialities. An initial set of strategies to minimize the risk of scar formation is applicable to all types of scars and is indicated before, during and immediately after surgery. In addition to optimal surgical management, this includes measures to reduce skin tension, and to provide taping, hydration and ultraviolet (UV) protection of the early scar tissue.


Silicone sheeting or gel is universally considered as the first-line prophylactic and treatment option for hypertrophic scars and keloids. The efficacy and safety of this gold-standard, non-invasive therapy has been demonstrated in many clinical studies. Other (more specialized) scar treatment options are available for high-risk patients and/or scars. Pressure garments may be indicated for more widespread scarring, especially after burns. At a later stage, more invasive or surgical procedures may be necessary for the correction of permanent unaesthetic scars and can be combined with adjuvant measures to achieve optimal outcomes. The choice of scar management measures for a particular patient should be based on the newly updated evidence-based recommendations taking individual patient and wound characteristics into consideration.

~Alster T, Tanzi E. The Washington Institute of Dermatologic Laser Surgery, WA USA

~Am J Clin Dermatol. 2003;4(4):235-43.


Keloid and hypertrophic scars have affected patients and frustrated physicians for centuries. Keloid and hypertrophic scars result from excessive collagen deposition, the cause of which remains elusive. Clinically, these scars can be disfiguring functionally, aesthetically, or both. A thorough understanding of the pathophysiology and clinical nature of the scar can help define the most appropriate treatment strategy. Although many articles have been published on the management of hypertrophic and keloid scars, there is no universally accepted treatment protocol.


Prevention of keloid and hypertrophic scars remains the best strategy; therefore, those patients with a predisposition to develop excessive scar formation should avoid nonessential surgery. Once a scar is present, there are many treatments from which to choose. Hypertrophic scars and keloids have been shown to respond to radiation, pressure therapy, cryotherapy, intralesional injections of corticosteroid, interferon and fluorouracil, topical silicone or other dressings, and pulsed-dye laser treatment. Simple surgical excision is usually followed by recurrence unless adjunct therapies are employed. Biologic agents that are directed towards the aberrant collagen proliferation that characterizes keloid and hypertrophic scars might be an important addition to the current armamentarium of modalities in the near future.

~Thomas A. Mustoe Northwestern University | NU - Division of Plastic Surgery

~Aesthetic Plastic Surgery 32(1):82-92 · February 2008 with 3,248 Reads


DOI: 10.1007/s00266-007-9030-9 · Source: PubMed


Silicone-based products are widely used in the management of hypertrophic scarring and keloids. This review discusses the range of products available and the clinical evidence of their efficacy in preventing excessive scarring and improving established scars. Silicone gel sheeting has been used successfully for more than 20 years in scar management. A new formulation of silicone gel applied from a tube forms a thin flexible sheet over the newly epithelialized wound or more mature scar.


Results from clinical trials and clinical experience suggest that silicone gel is equivalent in efficacy to traditional silicone gel sheeting but easier to use. The mechanism of action of silicone therapy has not been completely determined but is likely to involve occlusion and hydration of the stratum corneum with subsequent cytokine-mediated signaling from keratinocytes to dermal fibroblasts.

~Ahn ST, Monafo WW, Mustoe TA.

~Department of Surgery, Washington University School of Medicine, St Louis, MO.

~Arch Surg. 1991 Apr;126(4):499-504.


We studied the effects of a silicone gel bandage that was worn for at least 12 hours daily on the resolution of hypertrophic burn scar. In a second cohort, the prevention of hypertrophic scar formation in fresh surgical incisions by this bandage was also evaluated. In 19 patients with hypertrophic burn scars, elasticity of the scars was quantitated serially with the use of an elastometer. An adjacent or mirror-image hypertrophic burn scar served as a control.

Scar elasticity was increased after both 1 and 2 months compared with that in controls. There was corresponding improvement clinically that persisted for at least 6 months. In the other cohort, scar volume changes in 21 surgical incisions were measured before and after 1 and 2 months. Gel-treated incisions gained less volume than control incisions after both intervals. Clinical assessment corroborated this quantitative demonstration of a decrement in scar volume. We concluded that topical silicone gel is efficacious, both in the prevention and in the treatment of hypertrophic scar.

~Kim, Sukwha M.D., Ph.D.; Choi, Tae Hyun M.D., Ph.D.; Liu, Wei M.D., Ph.D.; Ogawa, Rei M.D., Ph.D.; Suh, Jeong Seok M.D.; Mustoe, Thomas A. M.D.
~Plastic and Reconstructive Surgery: December 2013 - Volume 132 - Issue 6 - p 1580–1589

DOI: 10.1097/PRS.0b013e3182a8070c


Following injury, Asian skin has a tendency towards hyperpigmentation and scar formation, and therefore the prevention of scarring is particularly important in Asian patients. Since the publication of an International Clinical Recommendation on Scar Management in 2002, there have been numerous publications in the field of scar management. Advances in understanding scar formation have also led to the introduction of new treatments as well as a better understanding of established therapeutic options.


A literature search for abstracts, clinical trials and meta-analyses evaluating scar prevention and treatment was performed using PubMed and the Cochrane Database of Systematic Reviews. Based on this data a panel of experts formulated treatment recommendations for Asian patients.


Following surgery, scar prevention should be initiated in all Asian patients due to the high risk of poor scars. There is strong evidence for the efficacy of silicone-based products, and due to their ease of use, they can be considered first-line therapy. Silicone gel (versus silicone gel sheets) products have demonstrated efficacy. For patients who fail to respond to first-line therapy, intralesional steroid injections, radiation therapy, and intralesional 5-fluorouracil injections have achieved widespread acceptance. Laser treatments have been increasingly used, although the evidence remains largely anecdotal without a clear consensus on optimal wavelength or amount of energy. Surgical approaches have increased in sophistication with recognition of the impact that tension has on scar formation.


Updated scar management recommendations will benefit practitioners making decisions regarding optimal, evidence-based treatment strategies for their patients.

~R. James Koch, MD

~Wound Healing and Tissue Engineering Laboratory

~Division of Otolaryngology/Head and Neck Surgery, Stanford University Medical Center, Stanford, CA


Topical silicone gel has shown promise in the treatment of hypertrophic and keloid scars. Fibroblast specimens were cultured in serum-free media and exposed to silicone gel. Serial cell counts were performed and supernatants were collected for bFGF quantification by enzyme-linked immunosorbent assay (ELISA) at 24, 72, and 120 hours.

Statistically significant differences were observed in bFGF levels between treated and untreated normal fibroblasts were observed at 24, 72, and 120 hours after cell culture initiation.

These results suggest that silicone gel is responsible for increased bFGF levels in dermal fibroblasts. We postulate that silicone gel treats and prevents hypertrophic scar tissue, which contains histologically normal fibroblasts by modulating expression of growth factors such as bFGF.

~R. James Koch, MD
~Wound Healing and Tissue Engineering Laboratory
~Division of Otolaryngology/Head and Neck Surgery, Stanford University Medical Center, Stanford, CA.


~Kin Yoong Chan, M.R. C.S. Ed.
~Chee Lan Lu, B. Sc. Pharm.
~Syed Mohd Adeeb, MS
~Sathappan Somsaundaram, F.R.C.S.
~Mohd Nasari-Zahari, F.R.C.S. Kuala Lumpur, Malaysia


Hypertrophic scarring caused by sternotomy is prevalent among Asians. The effectiveness of silicone gel in scar prevention pay influences the decision of surgeons and patients regarding its routine use during the postoperative period.


The authors conducted a randomized, placebo-controlled, double-blind, prospective clinical trial. The susceptibility to scar development varied among patients; therefore, sternal would were divided into the upper half and lower half. Two types of coded gel prepared by an independent pharmacist were used on either half. Thus, selection and assessment biases and confounders were eliminated. Results: One hundred wounds in 50 patients were randomized into two arms, patients control, and 50 silicone gels. The median age was 61 years and there were 35 men and 16 women. Ethnic distribution was 28 Malays, 18 Chinese, and four Indians. No side effect caused by the silicone gel was noted. Ninety-eight percent of patients had moderate to good compliance. The incidence of sternotomy scar was 94 percent. At the third month postoperatively, the silicone gel wounds were scored lower when compared with the control wounds. The differences were statistically significant in all parameters, including pigmentation (p= 0.20), vascularity (p= 0.001), pliability (p= 0.001), height (p= 0.001), pain (p= 0.001), and itchiness (p= 0.02). Conclusions: The effect of silicone gel in the prevention of hypertrophic scar development in sternotomy wounds is promising. There are no side effects and patients’ compliance is satisfactory. This study may popularize the use of silicone gel in all types of surgery to minimize the formation of hypertrophic scars in the early postoperative period. (Plast. Reconstr. Surg. 116: 1013, 2005.)