Development of a new dural sealing device from the bench to the neurosurgical bed
EANS Academy. van Doormaal T. 09/27/19; 276040; EP11015
Dr. Tristan van Doormaal
Dr. Tristan van Doormaal

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Background: Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4-32% of surgical cases depending on location of surgery and patient specific variables. Watertight dural closure remains an important step in preventing CSF leakage. We developed and tested a Dural Sealant Patch (DSP) for watertight dural closure.
Objective: To preclinically and clinically assess the safety and efficacy of the DSP as a means of reducing CSF leakage.
Methods: First approximately 2500 in-vitro experiments were performed on models designed to mimic the cranial dural closure procedure to test performance of currently approved dural sealants and to design a superiorly performing patch (DSP) with extreme adherence to dural tissue. All DSP biocompatibility tests according to ISO standards were subsequently performed. DSP performance was tested in a 12 month survival pig craniotomy model. Based on these results we started in 2019 an open-label, single-arm safety and efficacy study (ENCASE) in 3 European neurosurgical centers (n= 40 patients) with 12 months follow-up. Primary endpoint is an occurrence of one of the following events in the first 30 days: intraoperative leakage at 20 cm H2O PEEP, postoperative percutaneous CSF leakage, or postoperative wound infection.
Results Preclinical studies showed DSP to be biocompatible, and to be better adhering to dura compared to currently used sealants with higher acute and chronic. burst pressures. Interim analysis of the clinical trial (n=25 of which 6 infratentorial) showed no occurence of the primary endpoint.
Conclusion: DSP seems a promising device to achieve watertight dural closure. However, the ENCASE trial has yet to be completed. Subsequently a randomized controlled trial in Europe and the USA, comparing against best current surgical practice, will be performed.
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