title: (EVICEL) for Augmentation of Dural Closure: Results of a Preliminary Clinical Study.
abstract: The authors prospectively evaluated the safety and efficacy of a new fibrin sealant in patients undergoing emergency and elective cranial/spinal surgery with documented cerebrospinal fluid (CSF) leakage after sutured dural repair. This study was designed as a prospective, nonrandomized clinical trial. EVICEL® Fibrin Sealant (Johnson & Johnson, Somerville, NJ) was used in 72 patients with documented intraoperative CSF leakage after neurosurgical dural repair for a variety of pathologies. Intraoperative CSF leakage was either spontaneous or induced by a Valsalva maneuver. Patients were monitored for 1 month postoperatively with physical examinations, clinical laboratory analyses, and diagnostic imaging (CT or MRI). The sealant was effective in closing intraoperative CSF leakage in all patients but one. There were no sealant-related adverse events, and all clinical outcomes were consistent with expectations for seriously ill patients undergoing prolonged neurosurgical procedures. EVICEL® Fibrin Sealant provides a safe and effective watertight closure when used as an adjunct to sutured dural repair during cranial surgery.
authors.affiliation: Department of Neurosurgery San Giovanni Addolorata Hospital Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Gazzeri
authors.affiliation: Department of Neurosurgery San Giovanni Addolorata Hospital Rome, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Fiore
authors.affiliation: Regional Service of Neurosurgery Virgen de la Arrixaca University Hospital Murcia, Spain.
authors.forename: Marcelo
authors.initials: M
authors.lastname: Galarza