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.
Keywords: Children; burn; cicatrix; pressure garment; scar management; silicone.