The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.
This is a randomized, multi-center controlled study evaluating the effectiveness of EVICEL\* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
139
EVICEL is a human plasma derived fibrin sealant
Standard of care
Department of Neurosurgery, Ziekenhuis Oost Limburg
Genk, Belgium
Department of Neurosurgery, University Hospital of Liège
Liège, Belgium
Department of Neurosciences and Rehabilitation, Tampere University Hospital
Proportion of success
Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.
Time frame: Day 1 (intraoperative)
Incidence of CSF leakage
Time frame: Day 5 post-op
Incidence of CSF leakage
Time frame: Day 30 post-op
Incidence of adverse events
Time frame: up to 30 days post-op
Incidence of surgical site infections
Time frame: Day 5 and 30 post-op
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Tampere, Finland
Service de Neurochirurgie B, Hopital Neurologique de Lyon
Cedex, France
Klinik für Neurochirurgie, Universitätsklinikum Essen
Essen, Germany
Department of Neurosurgery, University Giessen-Marburg
Giessen, Germany
Department of Neurosurgery, Klinikum Ingolstadt GmbH
Ingolstadt, Germany
Department of Neurosurgery University Clinics of Schleswig-Holstein Campus Kiel
Kiel, Germany
VU Medical Centre
Amsterdam, Netherlands
Department of Neurosurgery, John Radcliffe Hospital
Headington, Oxford, United Kingdom
...and 2 more locations