title: A multicentre, prospective, randomized, controlled study to evaluate the use of a fibrin sealant as an adjunct to sutured dural repair.
abstract: BACKGROUND
  Obtaining intra-operative watertight closure of the dura is considered important in reducing post-operative cerebrospinal fluid (CSF) leak. The purpose of this study was to evaluate a fibrin sealant as an adjunct to sutured dural repair to obtain intra-operative watertight closure in cranial neurosurgery.
  
  
  METHODS
  This randomized, controlled multicenter study compared a fibrin sealant (EVICEL®Fibrin Sealant [Human]) to sutured dural closure (Control). Subjects underwent supratentorial or posterior fossa procedures. Following primary dural repair by sutures, the closure was evaluated for intra-operative CSF leak by moderately increasing the intracranial pressure. If present, subjects were randomized to EVICEL®or additional sutures (2:1 ratio), stratified by surgical approach. Following treatment, subjects were successful if no CSF leaks were present during provocative challenge. Safety was assessed to 30 days post-surgery, including incidence of CSF leakage.
  
  
  RESULTS
  One hundred and thirty-nine subjects were randomized: 89 to EVICEL®and 50 to Control. Intra-operative watertight closure was achieved in 92.1% EVICEL®-treated subjects versus 38.0% controls; a treatment difference of 54.1% (p < 0.001). The treatment differences in the supratentorial and posterior fossa strata were 49.1% and 75.7%, respectively (p < 0.001). The incidence of adverse events was similar between treatment groups. No deaths or unexpected serious adverse drug reactions were reported. CSF leakage within 30 days post-operatively was 2.2% and 2.0% in EVICEL®and control groups, respectively. In addition, 2 cases of CSF rhinorrhoea were observed in the EVICEL®group. Although not associated with the suture line where EVICEL®was applied, when combined with the other CSF leaks, the observed leak rate in the EVICEL®group was 4.5%.
  
  
  CONCLUSIONS
  These results indicate that EVICEL®is effective as an adjunct to dural sutures to provide watertight closure of the dura mater in cranial surgery. The study confirmed the safety profile of EVICEL®.
authors.affiliation: a Department of Neurosurgery , John Radcliffe Hospital , Oxford , UK.
authors.forename: Alexander L
authors.initials: AL
authors.lastname: Green
authors.affiliation: b ETHICON , Paris , France.
authors.forename: Axel
authors.initials: A
authors.lastname: Arnaud
authors.affiliation: c ETHICON Inc , Somerville , NJ , USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Batiller
authors.affiliation: d Department of Neurosurgery , Ninewells Hospital & Medical School , Dundee , UK.
authors.forename: Sam
authors.initials: S
authors.lastname: Eljamel
authors.affiliation: e Johnson & Johnson Medical , Livingston , UK.
authors.forename: Judi
authors.initials: J
authors.lastname: Gauld
authors.affiliation: e Johnson & Johnson Medical , Livingston , UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Jones
authors.affiliation: f Department of Neurosurgery , CHU de Sart Tilman , Liege , Belgium.
authors.forename: Didier
authors.initials: D
authors.lastname: Martin
authors.affiliation: g Department of Neurosurgery , University Clinics of Schleswig-Holstein , Kiel , Germany.
authors.forename: Maximilian
authors.initials: M
authors.lastname: Mehdorn
authors.affiliation: h Department of Neurosciences and Rehabilitation , Tampere University Hospital , Tampere , Finland.
authors.forename: Juha
authors.initials: J
authors.lastname: Ohman
authors.affiliation: i Department of Neurosurgery , Ziekenhuis Oost Limburg , Genk , Belgium.
authors.forename: Frank
authors.initials: F
authors.lastname: Weyns
keywords: cerebrospinal fluid leak; dural repair; fibrin sealant; watertight dural closure