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

Objective The dural sealant patch (DSP) is designed for watertight closure after cranial surgery. goal of this study to assess, the first time, safety and performance DSP as a means reducing cerebrospinal fluid (CSF) leakage in patients undergoing elective intradural surgery with procedure. Design First human, open-label, single-arm, multicentre 360-day (12 months) follow-up. Setting Three large tertiary reference neurosurgical centres, two Netherlands one Switzerland. Participants Forty procedures, stratified into 34 supratentorial six infratentorial trepanations. Intervention Each patient received dura mater sutures. Outcome measures Primary composite endpoint was occurrence following events: postoperative percutaneous CSF leakage, intraoperative at 20 cm H 2 O positive end-expiratory pressure or wound infection. Overall success defined achieving primary no more than patients. Secondary endpoints were device-related serious adverse events (AEs), pseudomeningocele thickness dura+DSP. Additional reoperation 30 days user satisfaction. Results No met endpoint. (serious) AEs observed. There incidences self-limiting confirmed on MRI. Thickness (mean±SD) 3.5 mm±2.0 day 7 2.1 mm±1.2 90. reoperated within days. Users reported satisfactory design intuitive application. Conclusions DSP, later officially named Liqoseal, safe potentially efficacious device intracranial surgery, favourable clinical handling characteristics. A randomised controlled trial needed assess Liqoseal efficacy against best current practice leakage. Trial registration number NCT03566602 .