A multicentre, prospective, randomized, controlled study to evaluate the use of a fibrin sealant as an adjunct to sutured dural repair

Alexander L Green; Axel Arnaud; Jonathan Batiller; Sam Eljamel; Judi Gauld; Peter Jones; Didier Martin; Maximilian Mehdorn; Juha Ohman; Frank Weyns

doi:10.3109/02688697.2014.948808

A multicentre, prospective, randomized, controlled study to evaluate the use of a fibrin sealant as an adjunct to sutured dural repair

Br J Neurosurg. 2015 Feb;29(1):11-17. doi: 10.3109/02688697.2014.948808. Epub 2014 Aug 12.

Authors

Alexander L Green¹, Axel Arnaud², Jonathan Batiller³, Sam Eljamel⁴, Judi Gauld⁵, Peter Jones⁵, Didier Martin⁶, Maximilian Mehdorn⁷, Juha Ohman⁸, Frank Weyns⁹

Affiliations

¹ a Department of Neurosurgery , John Radcliffe Hospital , Oxford , UK.
² b ETHICON , Paris , France.
³ c ETHICON Inc , Somerville , NJ , USA.
⁴ d Department of Neurosurgery , Ninewells Hospital & Medical School , Dundee , UK.
⁵ e Johnson & Johnson Medical , Livingston , UK.
⁶ f Department of Neurosurgery , CHU de Sart Tilman , Liege , Belgium.
⁷ g Department of Neurosurgery , University Clinics of Schleswig-Holstein , Kiel , Germany.
⁸ h Department of Neurosciences and Rehabilitation , Tampere University Hospital , Tampere , Finland.
⁹ i Department of Neurosurgery , Ziekenhuis Oost Limburg , Genk , Belgium.

PMID: 25112563
DOI: 10.3109/02688697.2014.948808

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^®.

Keywords: cerebrospinal fluid leak; dural repair; fibrin sealant; watertight dural closure.