A prospective, multicenter, randomized, two-arm, single-blind, investigational device exemption pivotal study.Objective.
To assess the efficacy and the safety of a polyethylene glycol (PEG) hydrogel spinal sealant (DuraSeal Spinal Sealant) as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain a watertight dural closure in patients undergoing an intentional durotomy during spinal surgery.Summary of Background Data.
If a watertight dural closure is not achieved, cerebrospinal fluid leak with associated complications may occur. The PEG hydrogel spinal sealant is an Food and Drug Administration (FDA)-approved adjunct to sutured dural repair in spine surgery. This synthetic, absorbable hydrogel sealant works in the presence of fluid, conforms to irregular surfaces, and demonstrates strong adherence and compliance to tissue, without interfering with underlying tissue visibility.Methods.
A total of 158 patients were treated at 24 centers after they were randomized on the basis of an approximately 2:1 ratio (sealant:control); 102 received the PEG hydrogel spinal sealant and 56 received standard care. The primary end point was intraoperative watertight closure. Secondary end points included evaluations of postoperative cerebrospinal fluid leak, infection, and wound healing.Results.
Patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (100% vs. 64.3%, P < 0.001). No statistical differences were seen in postoperative cerebrospinal fluid leak, infection, and wound healing. No neurologic deficits were seen attributable to the sealant.Conclusion.
The PEG hydrogel spinal sealant evaluated in this study is safe and effective for providing watertight closure when used as an adjunct to sutured dural repair during spinal surgery. This readily available tool is superior to other standard of care technologies commonly used to achieve intraoperative watertight dural closure.