Jodie Wiseman1, Robert S Ware2, Megan Simons3,4, Steven McPhail5,6, Roy Kimble1,4, Anne Dotta7, Zephanie Tyack1,6. 1. Children's Burns and Trauma Research Group, Child Health Research Centre, The University of Queensland, Brisbane, QLD, Australia. 2. Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia. 3. Department of Occupational Therapy, Queensland Children's Hospital, Brisbane, QLD, Australia. 4. Pegg Leditschke Children's Burns Centre, Queensland Children's Hospital, Brisbane, QLD, Australia. 5. Institute of Health and Biomedical Innovation, School of Public Health and Social Work, Queensland University of Technology, Kelvin Grove, QLD, Australia. 6. Centre for Functioning and Health Research, Metro South Health, Buranda, QLD, Australia. 7. Department of Medical Imaging and Nuclear Medicine, Queensland Children's Hospital, Brisbane, QLD, Australia.
Abstract
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.
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.
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