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 inc...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^(TM))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.展开更多
基金supported by an Australian National Health and Medical Research Council administered fellowship(#1161138).
文摘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^(TM))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.
