The Use of DuraMatrix-Onlay TM for Dural Reconstruction following Craniotomy for Tumor Resection: Results from 100 Consecutive Patients

Objective: Complications from craniotomy in brain tumor patients lead to worse clinical outcomes either from infection, reoperation, or delays in adjuvant therapies. We tested the hypothesis that DuraMatrixOnlay TM Collagen Dura Substitute Membrane potentially could reduce operative complications, and we report the unique characteristics of this onlay product in comparison to primary dural closure and other onlay products. Methods: We reviewed the demographic and surgical data with special attention addressed to postoperative complications in primary or metastatic brain tumor patients undergoing craniotomy. We excluded patients with a posterior fossa craniotomy requiring watertight dural closure, those with secondary exploration for post-operative CSF leaks, or who underwent transsphenoidal resection of pituitary lesions. Results: A total of 100 patients underwent craniotomy were treated with the DuraMatrixOnlay TM product. A significant number of patients were at risk for wound healing complications due to either: postoperative radiation (61%), prior craniotomy (26%), or previous brain irradiation (19%). Deep wound infections requiring surgical reexploration and intravenous antibiotics were encountered in six patients (6%), and three patients (3%) had superficial infections which resolved with oral antibiotics. Pseudomeningoceles were seen in three patients (3%), and five patients (5%) had cerebrospinal fluid leaks including one who developed meningitis. Delayed complications were not encountered in any patient, and there were no complications that could be attributed to the use of the dural substitute. Conclusion: We have demonstrated that the use of DuraMatrix-Onlay TM for dural reconstruction is safe and efficient. This product is a cost effective and beneficial alternative for those patients not amenable to primary dural closure. Introduction Primary watertight dural closure following craniotomy is not possible in every situation. This may be secondary to dural injury or laceration during exposure, dural shrinkage throughout the procedure, when the dura must remain open to accommodate brain swelling, or resection of the dura for duralbased lesions 1-3 . Numerous options for secondary closure include the use of suturable materials such as pericranium and galea or synthetic substances such as gortex and allograft or synthetic collagen-based products 4-6 . In many instances, watertight dural closure is not necessary, and the use of onlay products may be sufficient to recreate a barrier for the intracranial compartment while avoiding the time demands required for dural suturing. Several materials have been approved by the FDA as onlay products for dural reconstruction, however, data regarding their efficacy and utility is lacking. The premarket approval process requires significant animal and preclinical data regarding product integration and safety while minimal postmarket research evaluating the use of these agents in clinical context exists. Approved by the FDA in 2006, DuraMatrix-Onlay TM Collagen Dura Substitute Membrane (Collagen Matrix Inc., Oakland, NJ) is indicated as a dura substitute for the repair of the dura mater 7 . In an attempt to fill this void and determine the efficacy and complication rates associated with the use of such materials, we conducted a