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Study Design: A nonrandomized, two-armed prospective study., Objective: Water-tight dural closure is paramount to the prevention of cerebrospinal fluid (CSF) leakage and associated complications. Synthetic polyethylene glycol (PEG) hydrogel has been used as an adjunct to sutured dural repair; however, its expansion postoperatively is a concern for neurological complications. A low-swell formulation of PEG sealant was introduced as DuraSeal Exact Spine Sealant System (DESS). A Post-Approval Study was performed primarily to evaluate the safety and efficacy of DESS for spinal dural repair compared to current alternatives, in a large patient population, reflecting a real-world practice., Methods: A total of 36 sites in the United States enrolled 429 patients treated with DESS as an adjunct to dural repair in the spinal sealant group and 406 patients treated with all other modalities in the control arm, from October 2011 to June 2016. The primary endpoint was the incidence of CSF leak within 90 days of operation. The secondary endpoints evaluated were deep surgical site infection and neurological serious adverse events., Results: The CSF leakage in the DESS group (6.6%) was not significantly different from the control group (6.5%) ( p = .83), and there was no significant difference in the time to first leak. The two groups had no significant differences in deep surgical site infection (1.6% versus control 2.1%, p = .61) or proportion of subjects with neurological serious adverse events (2.9% versus control 1.6%, p = .516)., Conclusions: DuraSeal Exact Spinal Sealant is safe when compared to current alternatives for spinal dural repair., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The device is approved by the Food and Drug Administration. Although the authors have not received or will receive benefits for person or professional use from a commercial party related directly or indirectly to the subject of this manuscript, benefits have been or will be received but are directed solely to a research fund, foundation, educational institution, or other nonprofit organization with which the authors have been associated. The study and the preparation of the manuscript was supported by a commercial party related to the subject of the manuscript.