AFCell Medical has reported positive results from a clinical study of its amnion-based allograft membrane, AmnioClear wound covering, designed for reducing post-operative adhesions and pain during the repair of peroneal and posterior tibial tendons.
AmnioClear comprises native human amnion and chorion, consisting of collagen types I, III, IV, V and VI, Laminin, Fibronectin, Nidogen, Proteoglycans and endogenous proteins and peptides.
The retrospective study, which included 14 patients, assessed whether there are any adhesions between the tendon repair site and the surrounding tissues, including the overlying skin.
Subjective assessment of the motility of the overlying skin at the incision site and manual measurements of range of motion, were evaluated to identify if there are any restrictions related to the surgical site.
Bristol Foot Score and the Foot Function Index-validated scoring systems were also used to assess both pain and functional capacity.
In addition, to determine the relative thickness of the repair site, each site was assessed and compared to the adjacent tendon, as well as to the contralateral limb.
The results showed that out of 14 patients, 86% were clear of adhesions anywhere around the surgery site and 93% were adhesion-free at the tendon repair site 1.7 years after surgery, and in those patients with signs of adhesions, the effects were rated mild or moderate.
Previous studies of crosslinked amnion membranes in the canine laminectomy model also showed reductions in postlaminectomy epidural adhesions.
Cambridge Health Alliance podiatric surgery division chief and Harvard Medical School surgery assistant professor, Dr Adam Landsman, said the data showed less than 20% of patients operated with an AmnioClear overlay develop adhesions on surrounding tissues.
"Normally this is a very large problem in a variety of different surgical arenas, tendons being one of them," Landsman said.