title: Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: study protocol for a randomised controlled trial.
abstract: 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. 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.
  
  
  
  A 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.
  
  
  
  Results 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.
  
  
  
  Australian New Zealand Clinical Trials Registry, ACTRN12616001100482 . Registered on 5 August 2016.
authors.affiliation: Centre for Children's Burns and Trauma Research, Centre for Children's Health Research, The University of Queensland, Brisbane, QLD, Australia. jodie.wiseman@uqconnect.edu.au.
authors.forename: Jodie
authors.identifier: 0000-0002-0605-5710
authors.initials: J
authors.lastname: Wiseman
authors.affiliation: Pegg Leditschke Children's Burns Centre, Lady Cilento Children's Hospital, Brisbane, QLD, Australia.
authors.forename: Megan
authors.initials: M
authors.lastname: Simons
authors.affiliation: Centre for Children's Burns and Trauma Research, Centre for Children's Health Research, The University of Queensland, Brisbane, QLD, Australia.|Pegg Leditschke Children's Burns Centre, Lady Cilento Children's Hospital, Brisbane, QLD, Australia.
authors.forename: Roy
authors.initials: R
authors.lastname: Kimble
authors.affiliation: UQ Child Health Research Centre, The University of Queensland, Brisbane, QLD, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Ware
authors.affiliation: School of Public Health and Social Work and Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove, QLD, Australia.|Centre for Functioning and Health Research, Metro South Health, Buranda, QLD, 4102, Australia.
authors.forename: Steven
authors.initials: S
authors.lastname: McPhail
authors.affiliation: Centre for Children's Burns and Trauma Research, Centre for Children's Health Research, The University of Queensland, Brisbane, QLD, Australia.|Centre for Functioning and Health Research, Metro South Health, Buranda, QLD, 4102, Australia.
authors.forename: Zephanie
authors.initials: Z
authors.lastname: Tyack
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000367:Age Factors; D002056:Burns / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D002921:Cicatrix / Q000209:etiology / Q000517:prevention & control*; D002985:Clinical Protocols; D003020:Clothing / Q000009:adverse effects; D003131:Combined Modality Therapy; D006776:Hospitals, Pediatric; D006801:Humans; D015999:Multivariate Analysis; D011312:Pressure; D011793:Queensland; D012107:Research Design; D020034:Silicone Gels / Q000008:administration & dosage* / Q000009:adverse effects; D062606:Tertiary Care Centers; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D020034:Silicone Gels
keywords: Burns; Children; Pressure garment therapy; Randomised controlled trial; Scar management; Topical silicone gel