Single-arm, open-label, multicenter first in human study to evaluate the safety and performance of Dura Sealant Patch in reducing CSF leakage following elective cranial surgery: The ENCASE trial

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 CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.

Design: First in human, open-label, single-arm, multicenter study with 360 days (12 months) follow up. 

Setting: Three large tertiary reference neurosurgical centers, 2 in the Netherlands and 1 in Switzerland. 

Participants: Forty patients undergoing elective cranial neurosurgical procedures, stratified into 34 supra- and 6 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 H2O positive end-expiratory pressur...