Study DesignProspective, 3:1 randomized, single-blind, 14-center investigational study ObjectiveTo assess the safety and efficacy of a low-swell spinal sealant when used as an adjunct to sutured dural repair compared to standard of care methods to obtain watertight dural closure in subjects undergoing spinal surgery SubjectsEligible patients undergoing spinal surgery in whom, following closure of a planned durotomy with sutures, a spontaneous CSF leak or non-watertight closure (baseline Valsalva maneuver at 20- 25 cm H2O for 5-10 seconds) was observed Test Device (N=74)Synthetic, absorbable polyethylene glycol (PEG) hydrogel dural sealant (DuraSeal™ Exact Spine Sealant System, Integra LifeSciences, Plainsboro, NJ, USA) Control Group (N=24)Any standard method designed to provide intraoperative watertight closure (e.g., additional sutures, fibrin glue) Primary EndpointSuccess rate in obtaining intraoperative watertight dural closure Safety EndpointsPostoperative CSF leak, surgical site infection, and adverse events within 90 days post-surgery
Primary Endpoint: Intraoperative Watertight Closure % Subjects with Intraoperative Watertight Closure 73/7419/24 P = 0.003 * *Intent-to-treat analysis The one non-success subject was randomized to the spinal sealant group but received control treatment due to a device assembly error 95% CI: 92.7-100.095% CI: 57.8-92.9 Success rate in subjects receiving spinal sealant 100%
Safety Endpoint: CSF Leaks Through 90 Days Spinal Sealant (N=73) Control (N=24) Difference [95% CI] P Value 90-Day CSF Leaks8 (11.0%)3 (12.5%) † -1.5 [-16.6, 13.5]>0.99 CSF Fistula2 (2.7%)2 (8.3%)-5.6 [-17.3, 6.1]0.26 Pseudomeningocele (surgical intervention required) 3 (4.1%)1 (4.2%)-0.1 [-9.3, 9.1]>0.99 Pseudomeningocele (no surgical intervention required)* 3 (4.1%)1 (4.2%)-0.1 [-9.3, 9.1]>0.99 * After the completion of the study, the FDA revised the definition of CSF leak to include pseudomeningoceles noted on MRI/CT scans without related surgical intervention. † Two subjects in the control arm experienced an incisional CSF leak and one subject had an incidental finding of a CSF leak reported as a pseudomeningocele (one subject was reported under 2 categories but is included only once in the total).
Conclusions This study demonstrates the efficacy and safety of a low-swell formulation of a hydrogel PEG sealant as an adjunct to sutures in achieving watertight dural closure in durotomies. An on-going post-market study is assessing the safety and efficacy of this hydrogel sealant in both intentional and incidental durotomies.