PMID- 34321304
OWN - NLM
STAT- MEDLINE
DCOM- 20210804
LR  - 20210804
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 11
IP  - 7
DP  - 2021 Jul 28
TI  - 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.
PG  - e049098
LID - 10.1136/bmjopen-2021-049098 [doi]
LID - e049098
AB  - OBJECTIVE: 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. DESIGN: First in human, open-label, single-arm, 
      multicentre study with 360-day (12 months) follow-up. SETTING: Three large 
      tertiary reference neurosurgical centres, two in the Netherlands and one in 
      Switzerland. PARTICIPANTS: Forty patients undergoing elective cranial 
      neurosurgical procedures, stratified into 34 supratentorial and six 
      infratentorial trepanations. INTERVENTION: Each patient received one DSP after 
      cranial surgery and closure of the dura mater with sutures. OUTCOME MEASURES: 
      Primary composite endpoint was occurrence of one of the following events: 
      postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H(2)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. RESULTS: 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+/-SD) 3.5 mm+/-2.0 at day 7 and 2.1 mm+/-1.2 at 
      day 90. No patients were reoperated within 30 days. Users reported a satisfactory 
      design and intuitive application. CONCLUSIONS: 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. TRIAL REGISTRATION 
      NUMBER: NCT03566602.
CI  - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Van Doormaal, Tristan
AU  - Van Doormaal T
AUID- ORCID: 0000-0002-6299-3859
AD  - Department of Neurosurgery, Brain Center, University Medical Center, Utrecht 
      University, Utrecht, The Netherlands T.P.C.vandoormaal@umcutrecht.nl.
AD  - Department of Neurosurgery, Clinical Neuroscience Center, University Hospital 
      Zurich, Zurich, Switzerland.
FAU - Germans, Menno R
AU  - Germans MR
AD  - Department of Neurosurgery, Clinical Neuroscience Center, University Hospital 
      Zurich, Zurich, Switzerland.
FAU - Sie, Mariska
AU  - Sie M
AD  - Department of Neurosurgery, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The 
      Netherlands.
FAU - Brouwers, Bart
AU  - Brouwers B
AD  - Department of Neurosurgery, Brain Center, University Medical Center, Utrecht 
      University, Utrecht, The Netherlands.
FAU - Carlson, Andrew
AU  - Carlson A
AD  - Department of neurosurgery, University of New Mexico, Albuquerque, New Mexico, 
      USA.
FAU - Dankbaar, Jan Willem
AU  - Dankbaar JW
AD  - Department of Radiology and Nuclear Medicine, University Medical Center, Utrecht 
      University, Utrecht, The Netherlands.
FAU - Fierstra, Jorn
AU  - Fierstra J
AD  - Department of Neurosurgery, Clinical Neuroscience Center, University Hospital 
      Zurich, Zurich, Switzerland.
FAU - Depauw, Paul
AU  - Depauw P
AD  - Department of Neurosurgery, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The 
      Netherlands.
FAU - Robe, Pierre
AU  - Robe P
AD  - Department of Neurosurgery, Brain Center, University Medical Center, Utrecht 
      University, Utrecht, The Netherlands.
FAU - Regli, Luca
AU  - Regli L
AD  - Department of Neurosurgery, Clinical Neuroscience Center, University Hospital 
      Zurich, Zurich, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT03566602
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210728
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - *Cerebrospinal Fluid Leak/prevention & control/surgery
MH  - Dura Mater/surgery
MH  - *Elective Surgical Procedures
MH  - Humans
MH  - Netherlands
MH  - Neurosurgical Procedures/adverse effects
MH  - Postoperative Complications/epidemiology/prevention & control
MH  - Switzerland
PMC - PMC8320247
OTO - NOTNLM
OT  - clinical trials
OT  - neurosurgery
COIS- Competing interests: First author received a consultancy fee in the design phase 
      of the product from Polyganics BV, the Netherlands. None of the authors have any 
      other financial interest in the product or Polyganics BV in general.
EDAT- 2021/07/30 06:00
MHDA- 2021/08/05 06:00
PMCR- 2021/07/28
CRDT- 2021/07/29 05:57
PHST- 2021/07/29 05:57 [entrez]
PHST- 2021/07/30 06:00 [pubmed]
PHST- 2021/08/05 06:00 [medline]
PHST- 2021/07/28 00:00 [pmc-release]
AID - bmjopen-2021-049098 [pii]
AID - 10.1136/bmjopen-2021-049098 [doi]
PST - epublish
SO  - BMJ Open. 2021 Jul 28;11(7):e049098. doi: 10.1136/bmjopen-2021-049098.