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Published VersionCC BY V4.0, Open Access
Journal article
Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: study protocol for a randomised controlled trial
Trials, Vol.18, pp.1-9
2017
PMID: 28209175
Abstract
Background
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.
Methods
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.
Discussion
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.
Trial registration
Australian New Zealand Clinical Trials Registry, ACTRN12616001100482. Registered on 5 August 2016.
Details
- 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
- Authors
- Jodie Wiseman (Corresponding Author) - The University of QueenslandMegan Simons - Queensland Children’s HospitalRoy Kimble - Queensland Children’s HospitalRobert Ware - The University of QueenslandSteven McPhail - Queensland University of TechnologyZephanie Tyack - Metro South Health
- Publication details
- Trials, Vol.18, pp.1-9
- Publisher
- BioMed Central Ltd.
- Date published
- 2017
- DOI
- 10.1186/s13063-017-1820-z
- ISSN
- 1745-6215
- PMID
- 28209175
- Copyright note
- This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Grant note
- This study is funded by an Australian Government Research Training Scholarship to the PhD student and a research grant provided to The University of Queensland by Stratpharma. Contact details for Stratpharma, Darren Kerr, Chief Executive Officer, Centralbahnplatz 8, CH-4051 Basel, Switzerland.
- Organisation Unit
- School of Health - Occupational Therapy
- Language
- English
- Record Identifier
- 991113049502621
- Output Type
- Journal article
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