Abstract
OBJECTIVE: To evaluate the safety and performance of a synthetic dural sealant as an adjunct to standard surgical dural repair techniques to prevent cerebrospinal fluid (CSF) leakage. METHODS: This study was designed as a prospective, nonrandomized, single-center clinical trial. The dural sealant is a synthetic absorbable hydrogel. Consecutive series of patients scheduled for elective cranial and intradural spinal surgery were included until a total of 50 applications were achieved. It was used primarily as an adjunct to ensure watertight dural closure. The end point was defined as no leak with the Valsalva maneuver after dural sealant application. The patients were followed up for 3 months after surgery to check for CSF leakage, standard laboratory and neurological examinations, and possible adverse advents. RESULTS: Of the 49 patients, 46 were included and treated with the dural sealant because of spontaneous leak (n = 34; 69%) or leak after the Valsalva maneuver (n = 12; 25%). There was no leak in the other patients (n = 3; 6%). After application of the dural sealant, there was no leak in all 46 patients (100%). Of the 46 patients included, there was one case of overt CSF leak. One patient had a pseudomeningocele. There were no adverse events other than those related to the disease or to the surgical procedure itself. CONCLUSION: The dural sealant, a synthetic absorbable hydrogel, is a useful adjunct to achieve watertight dural closure. Application resulted in 100% closure of intraoperative CSF leaks. There are no evident adverse effects.
