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

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New research published ahead-of-print by the journal Spine has found that low-swell absorbable polyethylene glycol (PEG) hydrogel sealant provides better intraoperative watertight closure than standard of care during spine surgery.

In order to prevent complications of cerebrospinal fluid leak, watertight dural closure during spine surgery is of vital importance. Neill Wright, Washington University School of Medicine, who led the study, and colleagues write that previous studies “have proven the efficacy of a synthetic PEG hydrogel sealant in spinal surgery compared to standard of care.” Following these reports and given the potential concerns of swelling in spinal applications, the hydrogel was modified to a low-swell formulation.

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.

Wright and colleagues report that patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (98.6% vs 79.2%, p=0.003). Postoperative fluid leakage was also less frequent in the hydrogel group (6.8%) than in the control group (12.5%).

 

There were no differences in infection, wound healing or serious adverse events between the hydrogel and control groups. Serious neurological complications were comparable between the hydrogel (6.8%) and control (8.3%) groups, with any adverse neurological events in both groups related to underlying pathology rather than dural closure.

The authors note that “The low-swell PEG hydrogel spinal sealant evaluated in this study has been proven safe and effective for providing watertight closure when used as an adjunct to sutured closure of intentional durotomies during spinal surgery.” In concluding, Wright et al suggest that “PEG sealant is superior to standard of care methods in obtaining an intraoperative watertight closure, while remaining equivalent to standard of care methods in wound healing, infection and postoperative cerebrospinal fluid leakage.”

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