The effect of a tissue engineered bilayered living skin analog, over meshed split-thickness autografts on the healing of excised burn wounds. The Apligraf Burn Study Group.

The potential of Apligraf(R) (Graftskin) (Organogenesis Inc., Canton, MA), to improve cosmetic and functional outcomes when applied over meshed split thickness autografts was evaluated in a multicenter, randomized within patient controlled clinical trial. Experimental treatment sites had Apligraf(R) placed over meshed autograft while control sites were treated with meshed autograft covered with meshed allograft, or meshed autograft not covered by a biologic dressing. Forty patients were entered into this study of which 38 were evaluable. There was no difference in the percent take of autograft in the presence or absence of Apligraf(R) or in the median number of days to greater than 75% take of autograft. At the completion of the study 22 (58%) of the Apligraf(R) sites were rated superior to the control sites by the investigators, 10 (26%) were rated equivalent to the control and six (16%) were rated worse than control (p=0. 0037). Pigmentation, in the Apligraf(R) group was significantly better than control and by month 24, 17 (45%) Apligraf(R) sites had normal pigmentation compared with five (13%) control sites (p=0. 0005). Similarly by month 24, 18 (47%) patients had normal vascularity at the Apligraf(R) site compared with six (16%) patients at the control site. Improvements in pliability were observed with Apligraf(R) over control treatment within the first week of treatment. At month 24, 23 (61%) patients had normal height at the Apligraf(R) site compared to 14 (37%) with normal height at the control site (p=0.0117). Vancouver burn scar scores were shown to be statistically better at Apligraf(R) sites compared to control at all time points from week 1 to month 24. These results indicate that Apligraf(R) is a suitable and clinically effective treatment for burn wounds when applied over meshed autografts. Furthermore, cosmetic and functional advantages with Apligraf(R) were demonstrated when applied over meshed autograft compared to the current standard treatments of meshed autografts.

RCT Entities:   Population Interventions Outcomes