Collagen-only biomatrix as a novel dural substitute. Examination of the efficacy, safety and outcome: Clinical experience on a series of 208 patients.

OBJECTIVES: Dural replacement materials and other measures can provide an effective barrier between the subarachnoid compartment and the extradural space when a watertight closure of the patient's own dura is not possible. PATIENTS AND METHODS: We evaluated the efficacy and safety of a novel collagen-derived dural substitute on a series of 208 patients undergoing a variety of neurosurgical procedures. RESULTS: No patients experienced any local or systemic complications nor toxicity related to the dural patch. No patients experienced post-operative CSF fistula except for one. Post-operative MRIs showed signs of moderate inflammatory response in only one patient, who did not present any post-operative clinical symptom nor neurological deficits. Three patients underwent reoperation for bone flap repositioning after decompressive craniectomy: in these cases, the dural substitute appeared to have promoted a satisfactory dural regeneration, as confirmed by the histological studies. Furthermore, in such cases no or minimal adherences with the other tissues and the brain cortex was observed. CONCLUSIONS: The new collagen-only biomatrix is a safe and effective dural substitute for routine neurosurgical procedures. The absence of local and systemic toxicity or complications, and the scarce promotion of adherences and inflammation, make this material appealing for its use as dural substitute even in cases when a needed re-operation is anticipated.