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.