Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial

Carlson, Andrew P; Slot, Emma M H; van Doormaal, Tristan P C; ENCASE II study group; et al

doi:10.5167/uzh-220272

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Carlson, A. P., Slot, E. M. H., van Doormaal, T. P. C., ENCASE II study group, & et al. (2022). Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial. Trials, 23, 581. https://doi.org/10.1186/s13063-022-06490-8

Abstract

BACKGROUND

Cerebrospinal fluid (CSF) leakage is a frequent and challenging complication in neurosurgery, especially in the posterior fossa, with a prevalence of 8%. It is associated with substantial morbidity and increased healthcare costs. A novel dural sealant patch (LIQOSEAL) was developed for watertight dural closure. The objective of this study is to clinically assess the safety and effectiveness of LIQOSEAL as a means of reducing intra- as well as postoperative CSF leakage in patients undergoing elective posterior fossa intradu