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Dryad

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

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 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 pressure or postoperative wound infection. Overall success was defined as achieving the primary endpoint in no more than 2 patients. Secondary endpoints were device related serious adverse events (SAEs) 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 (S)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 re-operated 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 favorable clinical handling characteristics. A randomized controlled trial is needed to assess Liqoseal efficacy against the best current practice for reducing postoperative CSF leakage.

Strengths and limitations

  • The trial studies a device to prevent postoperative cerebrospinal fluid (CSF) leakage, which is one of the most common neurosurgical complications.
  • The study protocol was performed in multiple centers, registered, pre-published and strictly followed.
  • The composite endpoint of the trial reduced the number of inclusions needed.
  • The study did not involve a comparison to current clinical standard and has a potential selection bias, so generalization of results with regard to DSP efficacy needs to be cautiously undertaken.