Cerafix® Dura Substitute Effectively Repairs Small and Large Dural Defects Independent of Defect Size

Background: Dural substitutes are commonly utilized to repair dural defects incurred during routine neurosurgical procedures. The ideal dura substitute should effectively seal the defect, encourage neoduralization, and regenerate native dura prior to graft resorption. Cerafix® Dura Substitute is a novel non-biologic, fully-resorbable graft that has previously been shown to successfully repair critical dural defects and regenerate native dura in canine and rabbit models. Yet, the resorbable Cerafix® material has not been evaluated in the repair of larger dural defects sizes, where the time course of cellular ingrowth and neoduralization is prolonged. The present study aims to examine whether the resorption rate of the Cerafix® material is suitable for effective repair of large dural defects. Methods: The efficacy of Cerafix® Dura Substitute was evaluated in a canine duraplasty model. Small or large dural defects (equivalent to 1.9 in and 4.4 in dural defects in humans) were created bilaterally and then repaired with Cerafix® secured with non-tension sutures. Animals were monitored post-operatively for signs of CSF leak and neurological abnormalities. Repair sites were explanted 4 or 13 weeks after surgery and evaluated by histopathology to assess neoduralization, implant resorption, and local inflammation [12-14]. Results: Cerafix® was observed to effectively repair induced dural defects independent of the induced defect size. Both small and large dural defects were successfully repaired by Cerafix® Dura Substitute, which prevented CSF leakage and infection. Histopathology of the implant site revealed comparable neoduralization and vascularization between small and large defects both 4 and 13 weeks after surgery. Furthermore, histopathology confirmed that the gradual resorption of the graft was balanced by increasing neoduralization over time. By week 13 all defects were healed upon complete neoduralization across the implant site [12-14]. Conclusions: Cerafix® demonstrated an optimal time course of resorption suited for repair of both small and large dural defects*. Cerafix® provided immediate sealing of the dura mater, as well as gradual resorption, after which the graft was completely replaced with neodural tissue 13 weeks after surgery. The present study further demonstrates the ability of Cerafix® Dura Substitute to regenerate pristine dura in variable size defects.