{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T13:50:02Z","timestamp":1790085002019,"version":"4.0.1"},"reference-count":44,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2024,5,10]],"date-time":"2024-05-10T00:00:00Z","timestamp":1715299200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,5,10]],"date-time":"2024-05-10T00:00:00Z","timestamp":1715299200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Childs Nerv Syst"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>Cerebrospinal fluid (CSF) leakage is a challenging complication of intradural cranial surgery, and children are particularly at risk. The use of dural sealants confers protection in adults, but pediatric studies are scarce. We evaluated the safety and efficacy of Evicel<jats:sup>\u00ae<\/jats:sup> fibrin sealant as an adjunct to primary dural suturing in children undergoing cranial surgery.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A multicenter trial prospectively enrolled pediatric subjects (&lt;\u200918\u00a0years) undergoing cranial neurosurgery who, upon completion of primary sutured dural repair, experienced CSF leakage. As agreed by the EMA Evicel<jats:sup>\u00ae<\/jats:sup> Pediatric Investigation Plan, 40 subjects were intra-operatively randomized 2:1 to Evicel<jats:sup>\u00ae<\/jats:sup> or additional sutures (\u2018Sutures\u2019). Data analysis was descriptive. The efficacy endpoint was treatment success rate, with success defined as intra-operative watertight closure after provocative Valsalva maneuver (primary endpoint). Safety endpoints were postoperative CSF leakage (incisional CSF leakage, pseudomeningocele or both) and surgical site complications (secondary endpoints).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Forty subjects (0.6\u201317\u00a0years) were randomized to Evicel<jats:sup>\u00ae<\/jats:sup> (N\u2009=\u200925) or Sutures (N\u2009=\u200915) (intention-to-treat). Intracranial tumor was the most common indication and procedures were mostly supratentorial craniotomies. Success rates were 92.0% for Evicel<jats:sup>\u00ae<\/jats:sup> and 33.3% for Sutures, with a 2.76 estimated ratio of success rates (Farrington-Manning 95% CI [1.53, 6.16]). Sensitivity analyses in per-protocol and safety sets showed similar results. Despite a higher rescue treatment rate, the frequencies of postoperative CSF leakage and wound complications were higher for Sutures than for Evicel<jats:sup>\u00ae<\/jats:sup>.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>This small-scale prospective study shows Evicel<jats:sup>\u00ae<\/jats:sup> treatment to be safe and effective as an adjunct to primary sutured dura mater closure in a pediatric population. Compared to additional sutures, Evicel<jats:sup>\u00ae<\/jats:sup> was associated with reduced postoperative CSF leakage and surgical site complications. (Trial registration: The trial was registered as NCT02309645 and EudraCT 2013-003558-26).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00381-024-06434-4","type":"journal-article","created":{"date-parts":[[2024,5,10]],"date-time":"2024-05-10T05:01:51Z","timestamp":1715317311000},"page":"2735-2745","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Safety and effectiveness of Evicel\u00ae\u00a0fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery"],"prefix":"10.1007","volume":"40","author":[{"given":"Gnanamurthy","family":"Sivakumar","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6830-3695","authenticated-orcid":false,"given":"Shailendra","family":"Magdum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7015-5196","authenticated-orcid":false,"given":"Kristian","family":"Aquilina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jothy","family":"Kandasamy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivek","family":"Josan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6493-9103","authenticated-orcid":false,"given":"Bogdan","family":"Ilie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellie","family":"Barnett","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4142-4489","authenticated-orcid":false,"given":"Richard","family":"Kocharian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benedetta","family":"Pettorini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,5,10]]},"reference":[{"key":"6434_CR1","doi-asserted-by":"publisher","first-page":"1177","DOI":"10.1227\/neu.0000000000002345","volume":"92","author":"A Kinaci","year":"2023","unstructured":"Kinaci A, Slot EMH, Kollen M, Germans MR, Amin-Hanjani S, Carlson AP, Majeed K, Depauw P, Robe PA, Regli L, Charbel FT, van Doormaal TPC (2023) Risk factors and management of incisional cerebrospinal fluid leakage after craniotomy: a retrospective international multicenter study. 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B Ilie, E Barnett, R Kocharian are employees of Ethicon, Inc. E Barnett and R Kocharian receive stock options as part of employment with ETHICON. The authors do not have other competing interests to declare that are relevant to the content of this article.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}