A gelatin coated collagen-polyglycolic acid composite membrane as a dural substitute

We designed a new biodegradable composite membrane for use as a dural substitute. This membrane is composed of polyglycolic acid (PGA) mesh, collagen sponge, and gelatin sponge. Collagen layers are attached on both sides of the PGA mesh. One side of the membrane is coated with freeze-dried gelatin to prevent tissue adhesion. We examined the mechanical properties of the membrane and evaluated its efficacy in vivo by implanting it into dogs. When the mechanical properties of the membrane were measured under wet conditions, tensile strength and resistance against cutting by a suture were approximately 20 N/cm and 13 N, respectively, which are adequate for a surgical material. In the in vivo experiment, our dural substitute was implanted into six adult beagle dogs to repair a 25 x 15 mm defect in the dura mater. Two dogs each were killed at 2 and 4 months after implantation and two were observed over 6 months. At 4 months after implantation, the implanted dural substitute was almost absorbed and a fibrous membrane resembling native host dura had regenerated at the site. No foreign body reaction or significant adhesion to the cerebral cortex was observed. These results indicate the clinical potential of our novel dural substitute.