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




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Trials

, 18:72

First Online: 16 February 2017Received: 08 August 2016Accepted: 26 January 2017DOI: 10.1186-s13063-017-1820-z

Cite this article as: Wiseman, J., Simons, M., Kimble, R. et al. Trials 2017 18: 72. doi:10.1186-s13063-017-1820-z

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.

KeywordsBurns Scar management Randomised controlled trial Topical silicone gel Pressure garment therapy Children AbbreviationsCHU9DChild Health Utility 9D

EQ5D-YEuroQol 5D - Youth

HRECHuman Research Ethics Committee

ICCIntraclass correlation coefficient

ITTIntention-to-treat

NHMRCNational Health and Medical Research Council Guidelines

NRSNumeric rating scale

POSASPatient and Observer Scar Assessment Scale

RCTRandomised controlled trial

TBSATotal body surface area

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-017-1820-z contains supplementary material, which is available to authorized users.





Author: Jodie Wiseman - Megan Simons - Roy Kimble - Robert Ware - Steven McPhail - Zephanie Tyack

Source: https://link.springer.com/



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