None listed
Conditions
Brief summary
The RECELL® autologous cell harvesting device enables rapid autologous epidermal replacement. The paucity of data substantiating its implementation in acute paediatric burn injuries warrants further evaluation. This study aims to compare effectiveness of three commercially available burn wound management approaches used for burn injuries. Informed consent of parent/guardians of children meeting the inclusion criteria will be obtained the demographic data collected. Participants will be randomised to standard silver dressing or Biobrane® with RECELL® or Biobrane® only. These will be initially applied under a general anaesthetic in the operation theatre. Data acquisition will be from digital imaging, sonography, colorimetry and assessments of pain, itch, dressing application ease, treatment satisfaction, intervention fidelity, health- related quality of life, scar assessment and health resource utilisation will be recorded. Intervals for data collection will be at baseline, at all 3-5 day dressing changes until wound is 95% or more re-epithelialised and at outpatient follow up at 3, 6 and 12 months post injury.
Interventions
The initial dressing application will be conducted under a general anaesthetic within 48 hours of the burn injury. All participants will undergo a non-excisional debridement and cleaning with QV Wash prior to dressing application.
ARM 1: one of the two standard initial dressings Acticoat® (Smith and Nephew, Hull, UK) with Mepitel® (Molnlycke, Goteborg, Sweden) or Mepilex Ag® (Molnlycke, Goteborg, Sweden) will be applied. The second dressing change will occur 3-5 days after this. Each dressing c
The initial dressing application will be conducted under a general anaesthetic within 48 hours of the burn injury. All participants will undergo a non-excisional debridement and cleaning with QV Wash prior to dressing application. ARM 1: one of the two standard initial dressings Acticoat® (Smith and Nephew, Hull, UK) with Mepitel® (Molnlycke, Goteborg, Sweden) or Mepilex Ag® (Molnlycke, Goteborg, Sweden) will be applied. The second dressing change will occur 3-5 days after this. Each dressing change will be as per the standard procedure with research assessments at each dressing change until the wound is 95% or more re-epithelialised or referred for a graft. ARM 2: Once the wound bed is sufficiently prepared the surgeon will apply the autologous cell suspension using the RECELL® Autologous Cell Harvesting Device (AVITA Medical, California, USA) as per the manufacturer’s recommendations. A layer of Biobrane® (Smith & Nephew Medical Ltd, Hull, UK) will be laid over the top of the RECELL® and the edges will be secured with Hypafix® (BSN Medical GmBH, Hamburg, Germany). Over the top of the Biobrane® will be a layer of Jelonet® (Smith & Nephew Medical Ltd, Hull, UK) then Kerlix® (Covidien, Mansfield, Ma, USA), and crepe bandage; secured by Hypafix®. The Jelonet®, Kerlix®, Crepe and external Hypafix® will be changed every 3-5 days until the wound is 95% or more re-epithelialised or Biobrane® is completely detached from the neo-epithelium. DONOR SITE: The donor site location will be selected in a proximity as close as possible to the burn wound. The preparation of the site will undergo antimicrobial washing and irrigation. Once sufficient preparation has been achieved a pneumatic dermatome (Zimmer Inc., Warsaw, IN, USA) will be used to harvest a skin donor at a thickness of 6/1000 of an inch. Any excess autologous skin cell suspension will be applied to the donor site and dressed with inert standard dressing as per surgeon preference. ARM 3: Once the wound bed is sufficiently prepared the surgeon will apply a layer of Biobrane® over the burn, which will be secured with Hypafix®. Over the top of the Biobrane® will be a layer of Jelonet® then Kerlix®, Crepe bandage; secured by Hypafix®. The Jelonet®, Kerlix®, crepe bandage and external Hypafix® will be changed every 3-5 days until the wound is 95% or more re-epithelialised or Biobrane® is completely lifted. Most of dressing changes will be completed by our burns nursing staff and where required a surgeon will also assist with the dressing changes.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Age 16 years or older 2. Burn depth of superficial partial to mid-dermal thickness burns 3. Able to be recruited and treated within 48hours of burn injury 4. TBSA 5% or greater
Exclusion criteria
1. Burn depth of superficial, deep dermal or full thickness depth 2. Patients whose injuries are deemed not compatible with life by the attending burns surgeon
Outcome results
None listed