Burns research & reconstructive surgery
A randomised multi - centred trial to evaluate efficacy and safety of cultured epithelial autografts (CEA) in combination with a meshed (4:1) split skin graft (SSG) after debridement of a burn wound
Maitz P., Li Z., Nieuwendyk K., Harvey J., Vandervord J., Phoon A., Taggart S. and Kennedy P.
A piece of thin, split-thickness skin biopsy (about 4 cm2), taken under sterile conditions from a burn patient's available donor site, will be transported in biopsy transport medium to the Skin Culture Laboratory at Concord Hospital. Keratinocytes will be isolated from the separated epidermis following enzymatic digestion. The cells will be seeded into two cell culture flasks and cultivated under established laboratory conditions. The cells in one flask will be allowed to grow and differentiate into a cultured epidermal autograft (CEA) sheet while the cells in another flask will be maintained at the sub-confluent phase for preparing CEA suspension.
Prior to surgery the patient will undergo a Laser Doppler on the burn that will be in the study to diagnose depth.
The suspension will be randomly allocated to syringe A or B with the control syringe containing only transport media. On the day of surgery, both CEA sheet and suspension will be harvested under sterile conditions one hour before the surgery starts, labelled and then transported to the operating room in an esky with an ice brick.
On operation day (day 0) the burn wound will be debrided and a meshed SSG (4:1) will be applied and secured. Children will be in a separate study group and a suitable mesh size will be chosen by the surgeon. Four 10cm x 10cm window dressings (Surfasoft®) will then cover the SSG. Syringe A and B and a CEA sheet will then be applied to three of the windows and the forth will receive no additional treatment. The wounds will then be covered by a piece of Urgotul ® (except the graft with the CEA sheet as Urgotul® is all ready in situ as the carrier dressing) and Surfasoft® secured dressings as per protocol. The dressings will remain intact for five days and assessed and redressed until healed. Scarring will then be monitored at 26 weeks and finally at 52 weeks.