{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T13:51:05Z","timestamp":1790085065584,"version":"4.0.1"},"reference-count":17,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Operative Surg.","ONSURG"],"published-print":{"date-parts":[[2017,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    <jats:bold>BACKGROUND:<\/jats:bold>\n                    A watertight dural repair is critical to minimizing the risk of postoperative complications secondary to cerebrospinal fluid (CSF) leaks.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>OBJECTIVE:<\/jats:bold>\n                    To evaluate the safety and efficacy of a novel hydrogel, Adherus Dural Sealant, when compared with control, DuraSeal Dural Sealant System, as an adjunct to standard methods of dural repair.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>METHODS:<\/jats:bold>\n                    In this 17-center, prospective, randomized clinical trial designed as a noninferiority, single-blinded study, 124 patients received Adherus Dural Sealant (test sealant) and 126 received DuraSeal (control). The primary composite endpoint was the proportion of patients who were free of any intraoperative CSF leakage during Valsalva maneuver after dural repair, CSF leak\/pseudomeningocele, and unplanned retreatment of the surgical site. Each component was then analyzed individually as a secondary endpoint. Patients were followed for 4 mo after surgery.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>RESULTS:<\/jats:bold>\n                    The primary composite endpoint at the 120-d follow-up was achieved in 91.2% of the test sealant group compared with 90.6% of the control, thus showing that the test sealant was statistically significantly noninferior to DuraSeal (\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    = .0049). Post hoc analysis of the primary composite endpoint at 14 d demonstrated superiority of the test sealant over the control (\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    = .030). Primary endpoint failures in the control group tended to occur early in follow-up period, while a majority of test dural sealant failures were identified through protocol-required radiographic imaging at the 120-d follow-up visit.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>CONCLUSION:<\/jats:bold>\n                    The test sealant, Adherus Dural Sealant, is a practical, safe, and effective adjunct to achieving a watertight dural closure after primary dural closure in cranial procedures.\n                  <\/jats:p>","DOI":"10.1093\/ons\/opw004","type":"journal-article","created":{"date-parts":[[2017,8,16]],"date-time":"2017-08-16T15:49:19Z","timestamp":1502898559000},"page":"204-212","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":27,"title":["A Pivotal Randomized Clinical Trial Evaluating the Safety and Effectiveness of a Novel Hydrogel Dural Sealant as an Adjunct to Dural Repair"],"prefix":"10.1227","volume":"13","author":[{"given":"John M.","family":"Tew","sequence":"first","affiliation":[{"name":"Department of Neurosurgery, University of Cincinnati College of Medicine, Mayf-ield Clinic, Cincinnati, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Strong","sequence":"additional","affiliation":[{"name":"Tulane Uni-versity School of Medicine, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G. Alexander","family":"West","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Methodist Neurological Institute, Houston Methodist Hospital, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henry","family":"Woo","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, SUNY Stony Brook, Stony Brook, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel E.","family":"Couture","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John A.","family":"Wilson","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenzo F.","family":"Munoz","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles L.","family":"Rosen","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, West Virginia University, Morgantown, West Virginia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremy D.","family":"Greenlee","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of Iowa, Iowa City, Iowa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harry R.","family":"van Loveren","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of South Florida, Tampa, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Iantosca","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Penn State Hershey Medical Center, Hershey, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clinton J.","family":"Baird","sequence":"additional","affiliation":[{"name":"Oklahoma Spine and Brain Institute, Tulsa, Oklahoma"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Smith","sequence":"additional","affiliation":[{"name":"Carolina Neurosu-rgery & Spine Associates, Charlotte, North Carolina"},{"name":"The Carolinas Health-care System Neuroscience Institute, Charlotte, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matt","family":"McGirt","sequence":"additional","affiliation":[{"name":"Carolina Neurosu-rgery & Spine Associates, Charlotte, North Carolina"},{"name":"The Carolinas Health-care System Neuroscience Institute, Charlotte, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Parish","sequence":"additional","affiliation":[{"name":"Carolina Neurosu-rgery & Spine Associates, Charlotte, North Carolina"},{"name":"The Carolinas Health-care System Neuroscience Institute, Charlotte, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony L.","family":"Asher","sequence":"additional","affiliation":[{"name":"Carolina Neurosu-rgery & Spine Associates, Charlotte, North Carolina"},{"name":"The Carolinas Health-care System Neuroscience Institute, Charlotte, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2017,4]]},"reference":[{"issue":"9","key":"bib2-20240909","doi-asserted-by":"crossref","first-page":"827","DOI":"10.1007\/BF01411400","article-title":"Detailed evaluation of 2959 allogeneic and xenogeneic dense connective tissue grafts (fascia lata, pericardium, and dura mater) used in the course of 20 years for duraplasty in neurosurgery","volume":"139","author":"Parizek","year":"1997","journal-title":"Acta 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