Comparative Analysis of Cerafix® Dura Substitute and DuraMatrixTM Collagen Dura Substitute Membrane in a Large Animal Model of Dural Repair

Background: Dura substitutes are commonly required to repair the dura mater during routine neurosurgical procedures. Biologic materials composed of xenogenic collagen represent the most prevalent dura substitute, yet often incite undesirable tissue responses that impair wound healing. New materials are therefore needed to overcome the shortcomings of existing products and facilitate effective and reliable repair of native dura. The aim of the present study was to compare the performance of Cerafix® Dura Substitute, a novel non-biologic dura substitute, to DuraMatrixTM Collagen Matrix, a crosslinked bovine collagen dura substitute, as a means of facilitating dural repair. Methods: The biocompatibility and efficacy of Cerafix® was compared to DuraMatrixTM in a rabbit duraplasty model. Bilateral dura defects were repaired with either material and secured with non-tension sutures. Animals were monitored post-operatively for neurological sequelae and cerebrospinal fluid leak. Repair sites were explanted 4 weeks after implantation and evaluated by histopathology to assess neoduralization, cortical adhesion, implant resorption, local inflammation, and tissue response. Results: Both Cerafix® and DuraMatrixTM were effective in repairing dura defects and preventing cerebrospinal fluid leakage post-operatively. Histopathology revealed increased neoduralization and reduced cortical adhesion in defects repaired with Cerafix® versus site repaired with DuraMarixTM. Histological analysis further demonstrated that DuraMatrixTM induced a greater inflammatory response than Cerafix®, with greater infiltration of inflammatory cells in DuraMatrixTM implants at the terminal timepoint. Furthermore, DuraMatrixTM induced a greater fibrous capsule thickness compared to Cerafix®. Conclusions: Cerafix® and DuraMatrixTM demonstrated effective repair of induced dura defects and successfully prevented CSF leakage without infection or damage to underlying brain tissue. Cerafix® exhibited increased neoduralization, reduced cortical adhesions, and progressive resorption compared to DuraMatrixTM. Cerafix® further demonstrated less inflammation, irritation, and fibrosis than DuraMatrixTM. Cerafix® thereby provides a unique non-biologic option in dural repair procedures, and offer reduced risk of inflammation and adhesions commonly associated with traditional xenogenic collagen products.