Abstract
BackgroundAbnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar prevention and management techniques include silicone therapy, pressure garment therapy, or a combination of both.Currently, no definitive, high-quality evidence is available for the effectiveness of topical silicone gel or pressure garment therapy for the prevention and management of burn scars in the paediatric population. Thus, this study aims to determine the effectiveness of these treatments in children.MethodsA randomised controlled trial will be conducted at a large tertiary metropolitan children’s hospital in Australia. Participants will be randomised to one of three groups: Strataderm® topical silicone gel only, pressure garment therapy only, or combined Strataderm® topical silicone gel and pressure garment therapy. Participants will include 135 children (45 per group) up to 16 years of age who are referred for scar management for a new burn. Children up to 18 years of age will also be recruited following surgery for burn scar reconstruction. Primary outcomes are scar itch intensity and scar thickness. Secondary outcomes include scar characteristics (e.g. colour, pigmentation, pliability, pain), the patient’s, caregiver’s and therapist’s overall opinion of the scar, health service costs, adherence, health-related quality of life, treatment satisfaction and adverse effects. Measures will be completed on up to two sites per person at baseline and 1 week post scar management commencement, 3 months and 6 months post burn, or post burn scar reconstruction. Data will be analysed using descriptive statistics and univariate and multivariate regression analyses.DiscussionResults of this study will determine the effectiveness of three noninvasive scar interventions in children at risk of, and with, scarring post burn or post reconstruction.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12616001100482. Registered on 5 August 2016.
Highlights
The protocol for this study has been reported as per the Standard Protocol Items: Recommendations for Interventional Trial (SPIRIT) guidelines (Additional File 1) [1]
This study aims to determine the effectiveness of topical silicone gel versus pressure garment therapy versus combined topical silicone gel and pressure garment therapy, in the prevention and management of burn scars in children aged 0 to16 years post burn or 0 to18 years post burn scar reconstruction
Children who receive skin grafting, children with wounds that have not healed by day 17 post burn and children receiving surgery for burn scar reconstruction in all body locations with a total body surface area (TBSA) burned of less than or equal to 40% who are accompanied by a parent or guardian, who is able to provide informed consent, will be eligible for inclusion
Summary
The protocol for this study has been reported as per the Standard Protocol Items: Recommendations for Interventional Trial (SPIRIT) guidelines (Additional File 1) [1]. Abnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar prevention and management techniques include silicone therapy, pressure garment therapy, or a combination of both. No definitive, high-quality evidence is available for the effectiveness of topical silicone gel or pressure garment therapy for the prevention and management of burn scars in the paediatric population. Abnormal scars have a documented prevalence rate of 32 to 72% post burn [6, 10] and are defined as scars with physical and sensory symptoms that impact on health-related quality of life due to itch, raising, pain, tightness and contracture formation [5, 10]. Scar prevention and management interventions are initiated with the goal of preventing or reducing scar itch, thickness, erythema and pliability with the ultimate goal of maintaining or improving overall appearance of the scar and quality of life [13,14,15,16,17,18]
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