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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


van Doormaal, Tristan P C; Germans, Menno R; Sie, Mariska; Brouwers, Bart; Fierstra, Jorn; Depauw, Paul R A M; Robe, Pierre A; Regli, Luca (2020). 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. Neurosurgery, 86(2):E203-E208.

Abstract

BACKGROUND:
Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4% to 32% of surgical cases, with a higher incidence in complicated skull base surgery, intradural spine surgery, and the surgery of the posterior fossa. Our group developed a Dural Sealant Patch (DSP) for watertight dural closure after cranial surgery.
OBJECTIVE:
To clinically study for the first time the safety and performance of the DSP as a means of reducing CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.
METHODS:
We will conduct an open-label, single-arm, multicenter study with a 360 d (12 mo) follow-up. A total of 40 patients will be enrolled at 3 sites. The primary endpoint is a combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection. The secondary endpoints are pseudomeningocele and thickness of dura + DSP.
EXPECTED OUTCOMES:
Not more than 3 patients will meet the primary endpoint suggesting safety and efficacy.
DISCUSSION:
As a next step, a randomized controlled trial against the best current practice will follow to evaluate if DSP reduces CSF leakage while its safety is noninferior.
© Congress of Neurological Surgeons 2019.

Abstract

BACKGROUND:
Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4% to 32% of surgical cases, with a higher incidence in complicated skull base surgery, intradural spine surgery, and the surgery of the posterior fossa. Our group developed a Dural Sealant Patch (DSP) for watertight dural closure after cranial surgery.
OBJECTIVE:
To clinically study for the first time the safety and performance of the DSP as a means of reducing CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.
METHODS:
We will conduct an open-label, single-arm, multicenter study with a 360 d (12 mo) follow-up. A total of 40 patients will be enrolled at 3 sites. The primary endpoint is a combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection. The secondary endpoints are pseudomeningocele and thickness of dura + DSP.
EXPECTED OUTCOMES:
Not more than 3 patients will meet the primary endpoint suggesting safety and efficacy.
DISCUSSION:
As a next step, a randomized controlled trial against the best current practice will follow to evaluate if DSP reduces CSF leakage while its safety is noninferior.
© Congress of Neurological Surgeons 2019.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Neurosurgery
Dewey Decimal Classification:610 Medicine & health
Uncontrolled Keywords:Surgery, Clinical Neurology, CSF; Dura; Leakage; Prevention; Sealing
Language:English
Date:1 February 2020
Deposited On:20 Nov 2019 15:31
Last Modified:16 Jan 2020 02:04
Publisher:Oxford University Press
ISSN:0148-396X
OA Status:Green
Publisher DOI:https://doi.org/10.1093/neuros/nyz396
PubMed ID:31574157

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