Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children 12-months postburn: A parallel group randomised controlled trial

Objective: The longer-term effectiveness of silicone and pressure burn scar interventions was evaluated at 12-months postburn. Design: Parallel group, randomised trial. Setting: Hospital outpatient clinics, research centre. Participants: Children referred for burn scar management following grafted or spontaneously healed acute burn injuries or scar reconstruction surgery. Interventions: Participants were randomised to: (1) topical silicone gel only, (2) pressure garment only, or (3) combined topical silicone gel and pressure garment. Main measures: Primary outcomes were scar thickness (blinded ultrasound measurement) and itch intensity (caregiver proxy-report, numeric rating scale). Results: Of 153 participants randomised who received the interventions (silicone n = 51, pressure garment n = 49, combined n = 53), 86 were followed-up at 12-months postburn ( n = 34, n = 28, n = 24). No differences were identified for the primary outcomes using intention-to-treat analysis. Scar thickness mean difference (95% confidence interval) = 0.00 cm (−0.04, 0.05); −0.03 cm (−0.07, 0.02); 0.03 cm (−0.02, 0.08) and scar itch = 0.09 (−0.88, 1.06); −0.21 (−1.21, 0.79); 0.30 (−0.73, 1.32) for silicone vs pressure; silicone vs combined and combined vs pressure respectively. No serious adverse effects occurred. Conclusion: Similar to short-term results, the combined intervention offered no statistically or clinically significant benefit for improving the primary outcomes compared to each intervention alone. No differences in the primary outcomes were identified between the silicone and pressure alone groups.

Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: a randomized controlled trial

Objective: To determine the effectiveness of silicone and pressure garments (alone and in combination) in children receiving scar management post-burn. Design: Multicentre, parallel-group, randomized controlled trial. Setting: Hospital outpatient clinics, colocated research centre, or the participant’s home. Participants: Children (0–18 years) referred for burn scar management. Interventions: Participants were randomized to (1) topical silicone gel only, (2) pressure garment therapy only, or (3) combined topical silicone gel and pressure garment therapy. Main measures: Primary outcomes included scar thickness and itch intensity at the primary end-point of six months post-burn injury. The outcome assessor and data analyst were blinded for scar thickness. Results: Participants ( N = 153; silicone n = 51, pressure n = 49, combined n = 53) had a median (inter-quartile range) age of 4.9 (1.6, 10.2) years and percent total body surface area burn of 1% (0.5%, 3%) and were 65% male. At six months post-burn injury, intention-to-treat analysis identified thinner scars in the silicone ( n = 51 scar sites) compared to the combined group ( n = 48 scar sites; mean difference (95% confidence interval) = –0.04 cm (–0.07, –0.00), P = 0.05). No other between-group differences were identified for scar thickness or itch intensity at six months post-burn. Conclusion: No difference was identified in the effectiveness of silicone and pressure interventions alone. No benefit to a combined silicone and pressure intervention was identified for the prevention and management of abnormal scarring in children at six months post-burn injury, compared to the silicone or pressure interventions alone.