Advance Access: A Pivotal Randomized Clinical Trial Evaluating the Safety and Effectiveness of a Novel Hydrogel Dural Sealant as an Adjunct to Dural Repair

Of approximately 600 000 cranial neurosurgical procedures performed in the United States each year, more than half involve opening the dura mater.1Meticulous dural closure has long been advocated to help prevent complications, such as intracranial hemorrhage, hydrocephalus, focal neurological deficit, meningitis, pseudomeningocele, and cerebrospinal fluid (CSF) fistula. Standard methods of dural repair include use of running or interrupted sutures, occasionally supplemented with adhesives, hemostatic agents, and dural substitutes that include autologous, allogenic, or xenogenic collagenic connective tissue grafts, synthetic grafts and films, and newly formulated hydrogels.2,-4 Despite the use of these techniques, the incidence of postoperative CSF leak commonly ranges from 0.9% to 10.9%.5,-10Furthermore, many of the newer materials currently used to augment dural closures are associated with potential drawbacks, such as inadequate seal formation,11 central nervous system toxicity,12,13 and expansion in Situ that can cause compression of neural structures.14,15 Given the persistence of CSF leaks in clinical practice, an opportunity exists to refine current methods of dural closure. In this pivotal Food and Drug Administration (FDA) investigational device exemption clinical trial, 17 centers evaluated the safety and effectiveness of Adherus Dural Sealant when used as an adjunct to primary dural closure after a cranial procedure. This novel hydrogel was specifically formulated to address the most significant disadvantages to present methods of augmented dural closure such as lack of dimensional stability and variable mechanical strength of the sealant in the early postoperative period.16 Our multicenter trial evaluated primary and secondary endpoints during a 4-mo follow-up period and noted adverse events (AEs) by neurological evaluation, laboratory data, and magnetic resonance imaging (MRI) scans.

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