A Novel Absorbable Hydrogel for Dural Repair: Results of a Pilot Clinical Study

This report details a 47 patient, prospective, non-randomized, single-center clinical study to evaluate the safety and performance of a new synthetic dural sealant as an adjunct to standard surgical dural repair techniques to prevent cerebrospinal fluid (CSF) leakage. A consecutive series of patients scheduled for cranial and spinal intradural surgery each received standard dural closures. After sutured closure, 94% of patients had dural incisions that still exhibited intraoperative CSF leakage. Patients with intraoperative CSF leakage then had sealant applied to suture lines. Following sealant application, no patients exhibited intraoperative leakage during a subsequent Valsalva maneuver to 20 cmH2O (100% efficacy). Following surgery two patients developed overt postoperative CSF leaks, and one patient developed a pseudomeningocele. There were no adverse events other than those related to the disease or to the surgical procedure itself. This synthetic, absorbable dural sealant appears to be a useful adjunct to achieve watertight dural closure of sutured dura.