Controlled clinical study of deep partial-thickness burns treated with frozen cultured human allogeneic epidermal sheets.

Numerous studies, many uncontrolled, have suggested that the application of freshly prepared human allogeneic epidermal cultures promotes faster re-epithelialization of skin donor sites and deep partial-thickness burns. We describe the results of a study of deep partial-thickness burns treated with such cultures preserved in the frozen state. The study was controlled, side-by-side comparative, and randomized. Nine patients with deep partial-thickness burns and 2 patients with superficial partial-thickness burns were treated with the frozen cultures, with the use of adjacent wounds covered with petrolatum-coated gauze (Jelonet, Smith & Nephew Inc, Largo, Fla) as control wounds. The results showed that for the 2 superficial partial-thickness burns, the frozen cultures reduced healing time by 44%. For 5 of the patients with deep partial-thickness burns, the wounds treated with frozen cultures healed in a mean time of 5.6 days, whereas the control wounds healed in 12.2 days. More importantly, for the 4 other patients with deep partial-thickness burns, the wounds treated with the frozen cultures underwent complete re-epithelialization in a mean time of 4.2 days, but the control wounds were partially or mostly unhealed at up to 14 days. The results show that the frozen cultures not only accelerate the re-epithelialization of deep and superficial partial-thickness burns but also make it possible to heal such wounds that otherwise would not heal.

RCT Entities:   Population Interventions Outcomes