There were 98 patients included in the study between 2007 and 2009. There were 74 patients who received polyethylene glycol hydrogel sealant and 24 patients in a control group spread across 14 clinical sites in the United States. The patients in the control group received a standard method for intraoperative watertight closure.
The researchers found:
1. The patients who received the PEG hydrogel spinal sealant reported a 98.6 percent watertight closure rate, compared with 79.2 percent in the control group.
2. There were no statistical differences in these postoperative factors:
• Cerebrospinal fluid
• Infection
• Wound healing
3. The researchers didn’t find neurological deficits attributable to the sealant.
4. The PEG hydrogel spinal sealant in the study was low-swell and effective when used as an adjunct to sutured closure of intentional durotomies.
5. The researchers concluded, “PEG hydrogel sealants have again proved superior to other standard of care technologies for safe, efficacious dural closure.”
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