• van Doormaal Tristan P C TPC Department of Neurosurgery, Brain Center Rudolph Magnus, University Medical Centre Utrecht, Utrecht, The Netherlands. , Menno R Germans, Mariska Sie, Bart Brouwers, Jorn Fierstra, Paul R A M Depauw, Pierre A Robe, and Luca Regli.
• Department of Neurosurgery, Brain Center Rudolph Magnus, University Medical Centre Utrecht, Utrecht, The Netherlands.
• Neurosurgery. 2020 Feb 1; 86 (2): E203-E208.

BackgroundCerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4% to 32% of surgical cases, with a higher incidence in complicated skull base surgery, intradural spine surgery, and the surgery of the posterior fossa. Our group developed a Dural Sealant Patch (DSP) for watertight dural closure after cranial surgery.ObjectiveTo clinically study for the first time the 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.MethodsWe will conduct an open-label, single-arm, multicenter study with a 360 d (12 mo) follow-up. A total of 40 patients will be enrolled at 3 sites. The primary endpoint is a combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection. The secondary endpoints are pseudomeningocele and thickness of dura + DSP.Expected OutcomesNot more than 3 patients will meet the primary endpoint suggesting safety and efficacy.DiscussionAs a next step, a randomized controlled trial against the best current practice will follow to evaluate if DSP reduces CSF leakage while its safety is noninferior.© Congress of Neurological Surgeons 2019.

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