The feasibility of Negative Pressure Wound Therapy versus Standard Dressings in Paediatric Hand and Foot Burns Protocol: A Pilot, Single-Centre, Randomised Control Trial

Abstract

Abstract Introduction: The goal of paediatric hand and foot burn management is hypertrophic scar and/or contracture prevention. The risk of scar formation may be minimised by integrating Negative Pressure Wound Therapy (NPWT) as an acute care adjunct as it decreases the time to re-epithelialisation. NPWT has known associated therapeutic burden; however, this burden is hypothesised to be outweighed by an increased likelihood of hypertrophic scar prevention. This study will assess the feasibility, acceptability and safety of NPWT in paediatric hand and foot burns with secondary outcomes of time to re-epithelialisation, pain, itch, cost and scar formation. Methods and analysis: This is a single site, pilot randomised control trial. Participants must be aged ≤16-years, otherwise well and managed within 24hours of sustaining either a hand or foot burn. Thirty participants will be randomised to either standard care (Mepitel® – a silicone wound interface contact dressing – and ACTICOAT™ – a nanocrystalline silver-impregnated dressing) or standard care plus NPWT. Patients will be reviewed until three months post burn wound re-epithelialisation, with measurements taken at dressing changes to assess primary and secondary outcomes. Surveys, randomisation and data storage will be done via online platforms and physical data storage collated at the Centre for Children’s Health Research, Brisbane, Australia. Analysis will be performed using Stata statistical software. Ethics and Dissemination: Queensland Health and Griffith University Human Research ethics approval including a site-specific assessment was obtained. The findings of this study will be disseminated through clinical meetings, conference presentations and peer reviewed journals. Registration and Details: Registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12622000044729, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381890&isReview=true, registered 17/01/2022).