Efficacy and Safety of an Advanced Formula Silicone Gel for Prevention of Post-Operative Scars

Abstract

IntroductionScar formation is a natural part of the healing process that occurs when the skin repairs wounds caused by burns, trauma, surgery or disease. The appearance of scars often leads to adverse psychological effects, loss of self-esteem and the associated stigmatism and diminished quality of life. Silicones are emerging as the standard treatment for prevention of a wide range of scars. The present study evaluated the safety and efficacy of an advanced formula topical silicone gel for prevention of post-operative hypertrophic and keloid scars.MethodsAn open-label prospective trial was conducted. Patients who had undergone prior surgery (10 days–3 weeks) and having recent post-surgical scars were enrolled. Patients were asked to apply the gel twice daily to the affected areas for 3 months. Pigmentation, vascularity, pliability, height of scar and pain and pruritus in the scar were assessed. Photographs of scars were taken before commencement of treatment and at follow-up visits.ResultsA total of 36 patients were enrolled. At baseline, height of the scar was 2–5 mm in 57.6 % (19/33) of the subjects which was reduced in subsequent visits (P < 0.05). Hyperpigmentation (score 3) was present in 91% (30/33) of patients at baseline and was reduced to normal (score 0) after 2 months of treatment in 40% (6/14) of patients (P = 0.0313). Vascularity (54.6%, 18/33) at baseline was also reduced over the 3 months period (P = 0.0313) A significant decrease (30%, 3/10) (P = 0.0313) in pliability was seen after 3 months of treatment from the baseline (57.6%, 19/33). Only two patients reported pruritus and pain at the baseline visit; one patient reported improvement after treatment. Itching was reported as an adverse drug reaction in two patients.ConclusionThese preliminary findings suggest that advanced formula silicone gel is safe and effective in the prevention of hypertrophic and keloid scars; however, larger, controlled studies are warranted.Electronic supplementary materialThe online version of this article (doi:10.1007/s13555-013-0036-8) contains supplementary material, which is available to authorized users.

In Situ Cytokine Expression and Morphometric Evaluation of Total Collagen and Collagens Type I and Type III in Keloid Scars

“…Similar to our results, the literature shows that patients with keloid present an average age between 24 and 35.7 years [3, 38] and the appearance of these lesions occurs between 11 and 40 years [39]. It has been suggested that this age group is associated with hormonal changes, surgery, trauma [40], increased exposure to lesions by perforations, such as earrings/piercings [41], and also a higher recurrence during pregnancy [42].…”

“…Changes in these normal processes result in the formation of an exaggerated scar called keloid, characterized by growth of the lesion beyond the initial edges [2] and the nonspontaneous regression over the years [3]. …”

Comparison of the effectiveness of topical silicone gel and corticosteroid cream on the pfannenstiel scar prevention — a randomized controlled trial

“…Silicone gel treatment has been successfully employed for prevention of HS and keloid formation on different parts of the body [7,18,28,29]; however, it was not very effective on the Pfannenstiel incisions in our study. This could be due to the incision site at which HS and keloid formations are less common than in the other parts of the body.…”

“…In that study, silicone gel was associated with a significant reduction in the scores for scar pigmentation, vascularity, pliability, height, pain, itchiness (p ≤ 0.02), assessed by Vancouver Scar Scale(VSS), and it was suggested as promising in preventing HS. In a recent study, Medhi et al [18] investigated the efficacy of silicone gel in patients (n = 36) with recent surgical scars. After 3 months of treatment, significant improvements were observed in the height, pliability, and vascularity parameters (p = 0.015, p = 0.031, p = 0.031, respectively).…”

A Multicenter Randomized Controlled Trial Evaluating a Cx43-Mimetic Peptide in Cutaneous Scarring

“…The appearance of the scar is of utmost importance to patients, often reported as a greater concern than a successful outcome of the surgical procedure (Bush et al, 2010a, 2010b). Currently, no single therapy is universally accepted as the standard of care (SOC) to reduce postsurgical scarring, and, with the recent exception of silicone steroid gels designed for the treatment of hypertrophic and keloid scars (Chittoria and Padi, 2013; Medhi et al, 2013), no US Food and Drug Administration-approved products have produced consistent results for preventing, reducing, or eliminating excess deposition of scar tissue (Bush et al, 2011; Tziotzios et al, 2012). …”