A Prospective, Randomized, Placebo Controlled, Double Blind Study of Silicone Gel in Prevention of Hypertrophic Scar at Donor Site of Skin Grafting

BACKGROUND: Hypertrophic scarring at donor site of skin grafting is prevalent among Asians. The effectiveness of silicone gel in scar prevention may influence the surgeons and patients regarding its routine use during the postoperative period. AIMS AND OBJECTIVES: To study the efficacy of silicone gel in prevention of hypertrophic scars at donor site of skin grafting. DESIGN: Prospective randomized placebo controlled double blind study. SETTING: The study was conducted in the department of Plastic Surgery, Sri Venkateswara Institute of Medical Sciences (SVIMS) University, Tirupati, Andhra Pradesh, India from June 2007 to June 2009. Patients were recruited during follow-up in the OPD. MATERIALS AND METHODS: The susceptibility to scar development varied among patients; therefore, donor site scars were divided into 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: 100 scars in 50 patients were randomized into two arms, 50 control and 50 silicone gel. The median age was 25.5 years and there were 30 men (60%) and 20 women (40%). Thirty-seven patients (74%) had good compliance. The overall incidence of donor site hypertrophic scar was 94% (47 out of 50). At the second month postoperatively, the silicone gel scars were scored lower when compared with the control scars. The differences were statistically significant in all parameters, including pigmentation (P = 0.001), Vascularity (P = 0.010), pliability (P = 0.001), and height (P = 0.010). CONCLUSION: The effect of silicone gel in prevention of hypertrophic scar development in donor site scars is promising. Success of silicone gel in its prophylactic role will create its routine use in all types of surgery to minimize the formation of hypertrophic scars in the early postoperative period.