In vivo evaluation of bilayer ORC/PCL composites in a rabbit model for using as a dural substitute

Objective After a neurosurgical procedure, dural closure is commonly needed to prevent cerebrospinal fluids (CSF) leakage and to reduce the risk of complications, including infections and chronic inflammatory reactions. Although several dural substitutes have been developed, their manufacturing processes are complicated and costly and that many of them have been implicated in causing postoperative complications. This study aimed to assess the effectiveness and safety of new bilayer ORC/PCL composites in a rabbit model. Methods Two formulations of bilayer oxidized regenerated cellulose (ORC)/poly epsilon-caprolactone (PCL) knitted fabric-reinforced composites and an autologous graft (pericranium) were employed for dural closure in forty-five male rabbits. Systemic reaction and the local reaction of the samples were assessed and compared at one-, three- and six-months post-implantation by blood chemistry and gross, and microscopic assessment using hematoxylin-eosin and Masson's trichrome stains. Results No signs of CSF leakage or systemic infection were seen for all samples. All samples demonstrated minimal adhesion to adjacent tissues. The degree of host fibrous connective tissue ingrowth into both composites was comparable to that of the autologous group, but bone formation and osteoclast activities were significantly greater. Both composites progressively degraded over times and the residual thickness of the nonporous layer was 50% of the initial thickness at six months post-implantation. Discussion Bilayer ORC/PCL composites were successfully employed for dural closure in the rabbit model. They were biocompatible and could support dural regeneration comparable to that of the autologous group, but induced greater osteogenesis.