Study of negative pressure wound therapy as an adjunct treatment for acute burns in children (SONATA in C): Protocol for a randomised controlled trial
File version
Version of Record (VoR)
Author(s)
Griffin, B
Cuttle, L
McPhail, SM
Kimble, R
Griffith University Author(s)
Primary Supervisor
Other Supervisors
Editor(s)
Date
Size
File type(s)
Location
Abstract
Background: Although negative pressure wound therapy (NPWT) is widely used in the management of several wound types, its efficacy as a primary therapy for acute burns has not yet been adequately investigated, with research in the paediatric population particularly lacking. There is limited evidence, however, that NPWT might benefit children with burns, amongst whom scar formation, wound progression and pain continue to present major management challenges. The purpose of this trial is to determine whether NPWT in conjunction with standard therapy accelerates healing, reduces wound progression and decreases pain more effectively than standard treatment alone. Methods/design: A total of 104 children will be recruited for this trial. To be eligible, candidates must be under 17 years of age and present to the participating children's hospital within 7 days of their injury with a thermal burn covering <5% of their total body surface area. Facial and trivial burns will be excluded. Following a randomised controlled parallel design, participants will be allocated to either an active control or intervention group. The former will receive standard therapy consisting of Acticoat™ and Mepitel™. The intervention arm will be treated with silver-impregnated dressings in addition to NPWT via the RENASYS TOUCH™ vacuum pump. Participants' dressings will be changed every 3 to 5 days until their wounds are fully re-epithelialised. Time to re-epithelialisation will be studied as the primary outcome. Secondary outcomes will include pain, pruritus, wound progression, health-care-resource use (and costs), ease of management, treatment satisfaction and adverse events. Wound fluid collected during NPWT will also be analysed to generate a proteomic profile of the burn microenvironment. Discussion: The study will be the first randomised controlled trial to explore the clinical effects of NPWT on paediatric burns, with the aim of determining whether the therapy warrants implementation as an adjunct to standard burns management. Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12618000256279. Registered on 16 February 2018.
Journal Title
Trials
Conference Title
Book Title
Edition
Volume
20
Issue
1
Thesis Type
Degree Program
School
Publisher link
Patent number
Funder(s)
Grant identifier(s)
Rights Statement
Rights Statement
© The Author(s). 2019. 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.
Item Access Status
Note
Access the data
Related item(s)
Subject
Cardiovascular medicine and haematology
Clinical sciences
Paediatric, Burns, Negative-pressure Wound Therapy, Re-epithelialisation, Pain, Burn wound progression, Itch, Randomised controlled trial
Persistent link to this record
Citation
Frear, CC; Griffin, B; Cuttle, L; McPhail, SM; Kimble, R, Study of negative pressure wound therapy as an adjunct treatment for acute burns in children (SONATA in C): Protocol for a randomised controlled trial, Trials, 2019, 20 (1), pp. 130