Comparative effectiveness of Biobrane®, RECELL® Autologous skin Cell suspension and Silver dressings in partial thickness paediatric burns: BRACS randomised trial protocol

Abstract

Background: Mixed partial thickness burns are the most common depth of burn injury managed at a large Australian paediatric hospital specialty burns unit. Prolonged time until re-epithelialisation is associated with increased burn depth and scar formation. Whilst current wound management approaches have benefits such as anti-microbial cover, these are not without inherent limitations including multiple dressing changes. The Biobrane® RECELL® Autologous skin Cell suspension and Silver dressings (BRACS) trial aims to identify the most effective wound management approach for mixed partial thickness injuries in children. Methods: All children presenting with an acute burn injury to the study site will be screened for eligibility. This is a single-centre, three-arm, parallel group, randomised trial. Children younger than 16 years, with burns ≥ 5% total body surface area involving any anatomical location, up to 48 h after the burn injury, and of a superficial partial to mid-dermal depth, will be included. A sample size of 84 participants will be randomised to standard silver dressing or a Regenerative Epithelial Suspension (RES™) with Biobrane® or Biobrane® alone. The first dressing will be applied under general anaesthesia and subsequent dressings will be changed every 3 to 5 days until the wound is ≥ 95% re-epithelialised, with re-epithelialisation time the primary outcome. Secondary outcomes of acute pain, acute itch, scar severity, health-related quality of life, treatment satisfaction, dressing application ease and healthcare resource use will be assessed at each dressing change and 3, 6 and 12 months post-burn injury. Discussion: The findings of this study can potentially change the wound management approach for superficial partial to mid-dermal burns in children locally and worldwide. Trial registration: The Australian New Zealand Clinical Trials Registry (ACTRN12618000245291) approved prospective registration on 15 February 2018. Registration details can be viewed at https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374272&isReview=true.L6299189622019-12-02 <br />2019-12-09 <br />