None listed
Conditions
Brief summary
Abnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar management techniques include silicone therapy, pressure garment therapy, or a combination of both. Currently no definitive high quality evidence is available for the effectiveness, impact on health-related quality of life, health service costs, adherence and treatment satisfaction of topical silicone gel or pressure garment therapy for the prevention and management of burn scars in the paediatric population. Therefore evidence of the effectiveness of these treatments is required in children. A randomised controlled trial will be conducted. 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 burns scar reconstruction surgery. 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. Primary outcomes are scar thickness and scar itch intensity. Secondary outcomes include subjective scar severity (e.g. colour, pigmentation, pliability, pain, overall opinion), objective scar colour, health service costs, adherence, health-related quality of life, treatment satisfaction, and adverse effects. Measures will be completed up to 12-months post-burn or post-burn scar reconstruction. Data will be analysed using descriptive, univariate and multivariate statistics including regression analyses. The results of this study will determine the effectiveness of three non-invasive scar prevention interventions in children at risk of scarring post-burn or post-burn scar reconstruction.
Interventions
Comparing the effectiveness of topical silicone gel and pressure garment therapy for the prevention and management of paediatric burn scars.
Management of the acute burn will be conducted by the burns multidisciplinary team as per standard care. Potential participants referred to scar management will be approached for inclusion in the study and if consent is received, participants will be randomly allocated to receive either topical silicone gel (arm 1), pressure garment therapy (arm 2) or a com
Comparing the effectiveness of topical silicone gel and pressure garment therapy for the prevention and management of paediatric burn scars. Management of the acute burn will be conducted by the burns multidisciplinary team as per standard care. Potential participants referred to scar management will be approached for inclusion in the study and if consent is received, participants will be randomly allocated to receive either topical silicone gel (arm 1), pressure garment therapy (arm 2) or a combined topical silicone gel and pressure garment therapy intervention (arm 3). The intervention period is for up to 12 months post-burn or burn scar reconstruction. At the end of the last follow-up (12 months post-burn) ongoing scar management will be as per standard practice and will continue until scar maturation. Scar management appointments will be scheduled within the hospital setting according to clinical need, as determined by the treating Occupational Therapist. Research appointments will coincide with Occupational Therapy appointments at baseline (scar management commencement), 1 week post scar management commencement, 3, 6 and 12 months post burn or burn scar reconstruction. Participants will be provided with face-to-face verbal and written instructions regarding wear and care regimes of their allocated treatment. Participating occupational therapists will complete self-report fidelity checklists for each session and 20% of sessions will be audio recorded to assist with management of fidelity. Participants (and/ or their caregivers) will also complete self-report adherence questionnaires. Arm 1 = topical silicone gel only. Participants receiving topical silicone gel therapy will be provided with sufficient topical silicone gel to ensure adequate coverage of scars between review appointments. Strataderm topical silicone gel will be applied to the area as directed once/day. Participants (or their caregivers) will be directed to check that the silicone gel is still in contact with the burn scar 8-10 hours later by placing the affected part under running water to check for water beading. If this is not present, participants will be instructed to apply a second application of topical silicone gel (as per manufacturer’s instruction). Arm 2= pressure garment therapy only. Participants receiving pressure garment therapy will receive 2 sets of pressure garments when commencing scar management which will be replaced as frequently as deemed necessary by the treating occupational therapist. Participants will be instructed to wear their TSL pressure garment for 23hrs/ day. Style, fabric and the use of splinting etc. will be at the Occupational Therapists discretion.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
Children with a burn injury managed in the acute phase post-burn (up to 16 years of age) or who receive burn scar reconstructive surgery (up to 18 years of age). Children who require attendance at a scar management clinic after skin healing. Children who receive skin grafting after a burn injury, Children with wounds that have not healed by day 17 post-burn. Children who receive burn scar reconstructive surgery in all body locations. Children with a TBSA of less than or equal to 40% who are accompanied by a parent or guardian, who is able to provide informed consent. Children with a cognitive impairment that impedes the ability to communicate will be included, however, will not be required to complete self-report measures. Children and their families who do not speak English will be included but will not be required to complete all self-report measures.
Exclusion criteria
Children with comorbidities that might influence scar outcomes (such as a dermatological disorder); Children involved with the Department of Communities (Child Safety) where the burns consultant and/or burn team members consider study involvement to be contraindicated; Children with isolated facial or ear burns; Children with isolated genital burns; Children who are referred to their local health service before scar management is commenced.
Outcome results
None listed