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.
Learning from a cluster randomized controlled trial to improve healthcare workers’ access to prevention and care for tuberculosis and HIV in Free State, South Africa: the pivotal role of information systems
