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.