A Prospective Randomized Double-blind study of silicone gel plus Herbal Extracts Versus Placebo in Pre-sternal hypertrophic scar prevention and amelioration

OBJECTIVE: Post-surgical hypertrophic scar is more frequently reported in Asians. Many modalities can treat scars but there have not been any publications to define the efficacy of silicone gel plus herbal extracts for scar prevention or amelioration. DESIGN: 48 patients, who underwent median sternotomy were randomized and double-blinded to 2 groups to use topical silicone gel plus herbal extract gel or placebo for 6 months. Patients were treated either with topical silicone gel plus herbal extract gel or control using only placebo for 6 months. The scars were observed by experienced plastic surgeons using the Vancouver scar scale. SETTING: A single tertiary care center at Khon Kaen University. PATICIPANTS: 48 patients who underwent median sternotomy were enrolled in this study. All patients were aged over 18 years. All the wounds were sutured with polyglycolic 4/0 subcuticular suture material and did not receive other scar management before participating in this study. INTERVENTION: The silicone gel plus herbal extract gel (Bangkok Botanica, Bangkok, Thailand) in semi-liquid form was formulated from 15% Herbal extract (Allium Cepa extract, Centella Asiatica extract, Aloe Vera extract and Paper Mulberry extract), 50% polydemethysiloxane, 30% cyclopentasiloxane and 5% silica. The placebo gel was a composite of water, acrylate, C10-30 alkyl acrylate cross-polymer, polysorbate 20 and fragrance that was similar in color and consistency as that of the active gel and packed in the similar sealed packages. MAIN OUTCOME MEASURES: The scar was assessed using the Vancouver scar scale to determine pigmentation, vascularity, pliability and height. RESULTS: the study showed the silicone gel plus herbal extract gel could improve scar amelioration in height (p = 0.005) and pliability (p < 0.001) when compared to the placebo. The vascularity and pigmentation showed improvement using silicone gel plus herbal extracts but the improvement was not statistically significant. CONCLUSION: The silicone gel plus herbal extracts gel was effective for scar improvement in median sternotomy wounds.