The aim of this study is to evaluate the functional and cell biologica
l applicability of a two-ply nerve guide constructed of a PLLA/PCL (i.
e. poly-L-lactide and poly-epsilon-caprolactone) copolymer. To do so,
we performed a cytotoxicity test, a subcutaneous biodegradation test a
nd an in situ implantation study in the sciatic nerve of the rat. The
nerve guide copolymer was found to be non-toxic, according to ISO/EN s
tandards, and it showed a mild foreign body reaction and complete fibr
ous encapsulation after implantation. Onset of biodegradation of the i
nner layer was seen after one month of implantation. After 1 8 months
of implantation complete fragmentation was observed, as well as a seco
ndary inflammatory response. characterized by foreign body giant cell
activity and phagocytosis of polymer debris. Recovery of both motor an
d sensory nerve function was observed in all nerve guides.