Full-thickness cultured skin to heal significant burns without needing skin grafts

A prospective, 5 patient, non-controlled, non-blinded, single-arm pilot efficacy trial involving participants ranging from those with life-threatening burn injuries, up to and including those meeting the criteria for non-survivable burn injury (where this treatment offers the only chance of survival). All treatments will be administered during the participant's inpatient admission to the Royal Adelaide Hospital. At the first operation in the operating theatre, under general anaesthesia, the participant will have ALL deep burn excised.The operative area will be aggressively scrubbed with betadine-impregnated brushes, wet and dry Raytek gauze packs to clean the burns, remove all surface contaminants, loose non-viable material, etc. and shaved of hair. Skin preparation will be with Betadine™ (povidone iodine solution), unless the subject has a demonstrated history of iodine sensitivity/allergy when alcoholic chlorhexidine solution will be used. After draping, and under aseptic conditions, the deep areas of burn will be outlined for excision using a Sommerlad pen and Bonney’s Blue ink. The deep burn will be tumesced subcutaneously with a solution of 1:500,000 adrenaline and 0.05% bupivacaine to reduce intraoperative blood loss and post-operative pain. The burn will then be excised with a Watson-Humby knife to viable tissue. Haemostasis will be secured by bipolar diathermy and adrenaline-soaked packs (1:10,000). A biopsy (split skin graft) 10cm x 20cm harvested from unburned skin to create the autologous Composite Cultured Skin (CCS). This will be grown over the next 5 weeks. After this debridement, the wounds will be 'passively' temporised with an epidermal skin substitute (Biobrane). This will be overdressed with Acticoat, held by crepe bandages (limbs) or adhesive tapes (trunk). At a second operation (two or three days after the first operation also under general anaesthesia in theatre), the Biobrane will be removed, the wounds refreshed and BTM will be applied to all deep areas, except face, soles of feet and palms of hands. feet and hands. The BTM will be held in place with surgical steel staples. Overdressing will be with Acticoat™ nanocrystalline silver dressing held with hypafix on the trunk and crepe bandages on the limbs. Once recovered from anaesthesia, the patient will be returned to the ward, or Intensive Care Unit as required. The dressings will be taken down every three days for inspection. Evidence of material integration (colour, loss of foam pattern, general appearance) will be sought and recorded. Digital photographs will be taken. Staples will be removed at BTM delamination and CCS application. Dressing changes will occur on the ward every three days until the BTM is integrated and the CCS is ready for transplantation (about 5 weeks after the first operation) and the third operation is performed where the seal of the BTM is removed and the CCSs are applied, fixed and dressed under general anaesthetic. Dressings are again every three days until healing. The surgeries will all be performed by a specialist plastic surgery-trained burns surgeon with at least 10 years specialist burn surgery experience, with junior staff and theatre nurses. The intervention should need only one application, although in larger cases, some additional touch-up applications may be required. With burn injuries of this severity, early surgery is performed under two doctor, or third party consent. However, the participant is expected to be awake, cognisant and responsible by the time the CCS is ready for transplantation. At that stage, involvement in the trial will be discussed and information sheets provided to participant, next of kin and other family regarding the trial treatment, before informed consent is obtained, or involvement in the trial is refused.