Burns : journal of the International Society for Burn Injuries
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
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. ⋯ 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.