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.

ABSTRACT:

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 s

SUBMITTER: Van Doormaal T 

PROVIDER: S-EPMC8320247 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature