{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T18:12:20Z","timestamp":1790273540467,"version":"4.1.0"},"reference-count":14,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2021,7,27]],"date-time":"2021-07-27T00:00:00Z","timestamp":1627344000000},"content-version":"unspecified","delay-in-days":26,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Polyganics BV, Groningen, The Netherlands","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,6,21]]},"published-print":{"date-parts":[[2021,7]]},"abstract":"\n Objective<\/jats:title>\n The dural sealant patch (DSP) is designed for watertight dural closure after cranial surgery. The goal of this study is to assess, for the first time, safety and performance of the DSP as a means of reducing cerebrospinal fluid (CSF) leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n First in human, open-label, single-arm, multicentre study with 360-day (12 months) follow-up.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n Three large tertiary reference neurosurgical centres, two in the Netherlands and one in Switzerland.<\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n Forty patients undergoing elective cranial neurosurgical procedures, stratified into 34 supratentorial and six infratentorial trepanations.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Each patient received one DSP after cranial surgery and closure of the dura mater with sutures.<\/jats:p>\n <\/jats:sec>\n \n Outcome measures<\/jats:title>\n \n Primary composite endpoint was occurrence of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20\u2009cm H\n 2<\/jats:sub>\n O positive end-expiratory pressure or postoperative wound infection. Overall success was defined as achieving the primary endpoint in no more than two patients. Secondary endpoints were device-related serious adverse events or adverse events (AEs), pseudomeningocele and thickness of dura+DSP. Additional endpoints were reoperation in 30 days and user satisfaction.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n No patients met the primary endpoint. No device-related (serious) AEs were observed. There were two incidences of self-limiting pseudomeningocele as confirmed on MRI. Thickness of dura and DSP were (mean\u00b1SD) 3.5\u2009mm\u00b12.0 at day 7 and 2.1\u2009mm\u00b11.2 at day 90. No patients were reoperated within 30 days. Users reported a satisfactory design and intuitive application.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n DSP, later officially named Liqoseal, is a safe and potentially efficacious device for reducing CSF leakage after intracranial surgery, with favourable clinical handling characteristics. A randomised controlled trial is needed to assess Liqoseal efficacy against the best current practice for reducing postoperative CSF leakage.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n NCT03566602<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-049098","type":"journal-article","created":{"date-parts":[[2021,7,28]],"date-time":"2021-07-28T12:32:18Z","timestamp":1627475538000},"page":"e049098","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":11,"title":["Single-arm, open-label, multicentre first in human study to evaluate the safety and performance of dural sealant patch in reducing CSF leakage following elective cranial surgery: the ENCASE trial"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct03566602","registry":"10.18810\/clinical-trials-gov","type":"results"},{"clinical-trial-number":"nct04086550","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6299-3859","authenticated-orcid":false,"given":"Tristan","family":"Van Doormaal","sequence":"first","affiliation":[{"name":"Department of Neurosurgery, Brain Center, University Medical Center, Utrecht University, Utrecht, The Netherlands"},{"name":"Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Menno R","family":"Germans","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariska","family":"Sie","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bart","family":"Brouwers","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Brain Center, University Medical Center, Utrecht University, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Carlson","sequence":"additional","affiliation":[{"name":"Department of neurosurgery, University of New Mexico, Albuquerque, New Mexico, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan Willem","family":"Dankbaar","sequence":"additional","affiliation":[{"name":"Department of Radiology and Nuclear Medicine, University Medical Center, Utrecht University, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorn","family":"Fierstra","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Depauw","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Robe","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Brain Center, University Medical Center, Utrecht University, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca","family":"Regli","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,7,28]]},"reference":[{"key":"2025121223353231000_11.7.e049098.1","doi-asserted-by":"crossref","first-page":"735","DOI":"10.3171\/2014.6.JNS131917","article-title":"Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial","volume":"121","author":"Hutter","year":"2014","journal-title":"J Neurosurg"},{"key":"2025121223353231000_11.7.e049098.2","doi-asserted-by":"crossref","first-page":"490","DOI":"10.1016\/j.surneu.2005.03.041","article-title":"Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases","volume":"64","author":"Grotenhuis","year":"2005","journal-title":"Surg Neurol"},{"key":"2025121223353231000_11.7.e049098.3","unstructured":"FDA . Summary of safety and effectiveness data of DuraSeal dural sealant system, 2005. Available: https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf4\/P040034b.pdf [Accessed 22 Sep 2020]."},{"key":"2025121223353231000_11.7.e049098.4","doi-asserted-by":"crossref","first-page":"368","DOI":"10.1016\/j.wneu.2018.06.196","article-title":"Effectiveness of dural sealants in prevention of cerebrospinal fluid leakage after craniotomy: a systematic review","volume":"118","author":"Kinaci","year":"2018","journal-title":"World Neurosurg"},{"key":"2025121223353231000_11.7.e049098.5","unstructured":"FDA . Summary of safety and effectiveness data of DuraSeal spine sealant system, 2009. Available: https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf8\/P080013b.pdf [Accessed 22 Sep 2020]."},{"key":"2025121223353231000_11.7.e049098.6","unstructured":"Standardization IOf . ISO 10993-1:2009 biological evaluation of medical devices, 2009. Available: https:\/\/www.iso.org\/standard\/68936.html [Accessed 22 Sep 2020]."},{"key":"2025121223353231000_11.7.e049098.7","unstructured":"Commission E . MEDDEV 2.7\/3 rev.3 clinical investigations: serious adverse reporting under directives 90\/385\/EEC and 93\/42\/EC, 2015. Available: http:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/current-directives\/guidance_en [Accessed 22 Sep 2020]."},{"key":"2025121223353231000_11.7.e049098.8","unstructured":"Commission E . Meddev 2.7\/4 guidelines on clinical investigation: a guide for manufacturers and notified bodies, 2010. Available: http:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/current-directives\/guidance_en [Accessed 22 Sep 2020]."},{"key":"2025121223353231000_11.7.e049098.9","unstructured":"Association WM . Declaration of Helsink 2013."},{"key":"2025121223353231000_11.7.e049098.10","unstructured":"Standardization IOf . ISO 14155:2011. clinical investigation of medical devices for human subjects \u2013 good clinical practice, 2011. Available: https:\/\/www.iso.org\/standard\/45557.html [Accessed 22 Sep 2020]."},{"key":"2025121223353231000_11.7.e049098.11","doi-asserted-by":"crossref","first-page":"E203","DOI":"10.1093\/neuros\/nyz396","article-title":"Single-arm, open-label, multicenter study to evaluate the safety and performance of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery: the ENCASE trial study protocol","volume":"86","author":"van Doormaal","year":"2020","journal-title":"Neurosurgery"},{"key":"2025121223353231000_11.7.e049098.12","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0000000000004180"},{"key":"2025121223353231000_11.7.e049098.13","doi-asserted-by":"crossref","first-page":"498","DOI":"10.1016\/j.wneu.2011.12.011","article-title":"A multicenter, single-blind, prospective randomized trial to evaluate the safety of a polyethylene glycol hydrogel (Duraseal dural sealant system) as a dural sealant in cranial surgery","volume":"78","author":"Osbun","year":"2012","journal-title":"World Neurosurg"},{"key":"2025121223353231000_11.7.e049098.14","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1080\/02688697.2020.1735301","article-title":"Treatment of CSF leakage and infections of dural substitute in decompressive craniectomy using fascia lata implants and related anatomopathological findings","volume":"35","author":"Callovini","year":"2021","journal-title":"Br J Neurosurg"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-049098","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T07:35:40Z","timestamp":1765611340000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-049098"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7]]},"references-count":14,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2021,7,28]]},"published-print":{"date-parts":[[2021,7]]}},"alternative-id":["10.1136\/bmjopen-2021-049098"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-049098","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7]]}}}