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 has included 14 patients, is designed to demonstrate whether or not 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.
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 post-surgery, on average, and those patients with signs of adhesions the effects were rated mild or moderate.
Cambridge Health Alliance podiatric surgery division chief and Harvard Medical School surgery assistant professor Dr. Adam Landsman said, "Our data showed that less than 20% of the patients operated on with an AmnioClear overlay get adhesions on the surrounding tissues."