TY - JOUR
T1 - 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
T2 - The ENCASE trial
AU - Van Doormaal, Tristan
AU - Germans, Menno R.
AU - Sie, Mariska
AU - Brouwers, Bart
AU - Carlson, Andrew
AU - Dankbaar, Jan Willem
AU - Fierstra, Jorn
AU - Depauw, Paul
AU - Robe, Pierre
AU - Regli, Luca
N1 - Funding Information:
Funding This study was funded by Polyganics BV, Rozenburglaan 15A, 9727 DL Groningen, The Netherlands. Grant number: N/A.
Publisher Copyright:
© Authors 2021
PY - 2021/7/28
Y1 - 2021/7/28
N2 - 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.
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.
KW - clinical trials
KW - neurosurgery
UR - http://www.scopus.com/inward/record.url?scp=85111689335&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-049098
DO - 10.1136/bmjopen-2021-049098
M3 - Article
C2 - 34321304
AN - SCOPUS:85111689335
SN - 2044-6055
VL - 11
SP - 1
EP - 6
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e049098
ER -