title: A randomized, placebo-controlled, double-blind, prospective clinical trial of silicone gel in prevention of hypertrophic scar development in median sternotomy wound.
abstract: BACKGROUND
  Hypertrophic scarring caused by sternotomy is prevalent among Asians. The effectiveness of silicone gel in scar prevention may influence the decision of surgeons and patients regarding its routine use during the postoperative period.
  
  
  METHODS
  The authors conducted a randomized, placebo-controlled, double-blind, prospective clinical trial. The susceptibility to scar development varied among patients; therefore, sternal wounds were divided into the upper half and the 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, 50 control and 50 silicone gels. The median age was 61 years and there were 34 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 = 0.02), 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 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.
authors.affiliation: Division of Plastic and Reconstructive Surgery, Department of Pharmacy, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia. kychan71@tm.net.my
authors.forename: Kin Yoong
authors.initials: KY
authors.lastname: Chan
authors.forename: Chee Lan
authors.initials: CL
authors.lastname: Lau
authors.forename: Syed Mohd
authors.initials: SM
authors.lastname: Adeeb
authors.forename: Sathappan
authors.initials: S
authors.lastname: Somasundaram
authors.forename: Mohd
authors.initials: M
authors.lastname: Nasir-Zahari
mesh_terms: D000328:Adult; D000368:Aged; D006348:Cardiac Surgical Procedures; D017439:Cicatrix, Hypertrophic / Q000208:ethnology / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020034:Silicone Gels / Q000627:therapeutic use*; D013249:Sternum / Q000601:surgery*
chemical_list: D020034:Silicone Gels