Spinal sealant system provides better intraoperative watertight closure than standard of care

It was this low-swell formulation that the authors analysed in this study, using it as an adjunct to sutured dural repair compared to standard of care methods to obtain watertight dural closure in subjects undergoing spinal surgery. The authors decided to explore this approach given the elusiveness of successful dural closure using only sutures, with postoperative cerebrospinal fluid leakage rates as high at 17.4%. Though “various haemostatic or gelation sponge products have been used in off-label applications in attempts to reduce these rates,” Wright and colleagues write that all are known to swell after application, hence the development of the low-swell formulation used in this study.

Ninety-eight patients were randomised at 14 US sites between May 2007 and May 2009, 74 of whom were treated with PEG hydrogel spinal sealant and 24 put in the control group. The primary endpoint for the study was the success rate in obtaining intraoperative watertight dural closure. The patients were evaluated at 30 and 90 days post-procedure for cerebrospinal fluid leaks, surgical site infections, and adverse events.