Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: study protocol for a randomised controlled trial

Wiseman, Jodie, Simons, Megan, Kimble, Roy, Ware, Robert, McPhail, Steven and Tyack, Zephanie (2017) 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, 18 1: . doi:10.1186/s13063-017-1820-z


Author Wiseman, Jodie
Simons, Megan
Kimble, Roy
Ware, Robert
McPhail, Steven
Tyack, Zephanie
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
Journal name Trials   Check publisher's open access policy
ISSN 1745-6215
1468-6708
Publication date 2017-02-16
Sub-type Article (original research)
DOI 10.1186/s13063-017-1820-z
Open Access Status DOI
Volume 18
Issue 1
Total pages 9
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2018
Language eng
Formatted 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.
Keyword Burns
Children
Pressure garment therapy
Randomised controlled trial
Scar management
Topical silicone gel
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: UQ Centre for Clinical Research Publications
HERDC Pre-Audit
Child Health Research Centre Publications
 
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