Twenty RCTs were included in the review (n was unclear but seemed to be approximately 881). Sample sizes ranged from 10 to 149 patients, where reported. Sixteen studies were of burns management. Four studies were of management of donor sites.
The quality of the included studies was average. The RCTs that were included had small sample sizes and methodological detail was poorly reported.
Burns Management:
Biobrane and TransCyte were found to be more effective than silver sulfadiazine for partial thickness burns (less than 15% total body surface area). Wound infection was similar in Biobrane and silver sulfadiazine groups (two studies). Biobrane was significantly more effective than silver sulfadiazine for wound healing time (four studies) and wound closure (two studies) (there were similar results for TransCyte). TransCyte was more effective for wound healing time compared with silver sulfadiazine and topical antibiotics (three studies). Good adherence was reported for treating facial burns with TransCyte (three studies). There was no wound infection in TransCyte patients, compared with mild cellulitis in six patients with silver sulfadiazine (one study). Two studies reported no wound infections in either the TransCyte or topical antibiotics groups. Skin grafts were not needed for patients treated with TransCyte (two studies), but were required for 14% of patients treated with silver sulfadiazine (one study).
For wound closure, full thickness burns showed more granulation with allograft (74%) compared with Dermagraft (51%) (two studies). There were no significant differences between dermagraft and allograft for partial or full thickness burns for wound infection (two studies), healing time (one study) and graft uptake (wound closure) (two studies). Biological skin replacements were more efficacious than Integra in wound closure, but had a significantly longer wound healing time than Integra (one study). There were high rates of infection with Integra in one study in which patients had burns that were greater than 45% total body surface area.
Apligraf combined with autograft were effective for burns between 20% and 50% total body surface area. Apligraf and autograft was more effective than autograft in wound healing time greater than 75% (one study). There was no significant difference in wound closure with greater than 75% graft take (one study).
Management of donor sites:
Wound healing time was significantly longer for wounds covered with Biobrane compared with sites treated with allogeneic cultured keratinocytes (two studies). Wound closure post-surgery was significantly faster with OrCel compared with Biobrane. There was no difference between Biobrane and OrCel in wound infection (one study). There was no difference in wound infection, but wounds treated with OpSite took longer to heal compared to allogeneic cultured skin treatment.
Mortality rates were high. It was unclear whether this was due to the use of bioengineered skin substitute or actual burn injury.
Patient-related outcomes and further results were reported in the paper.