The Evicel Neurosurgery Phase III Study
Research type
Research Study
Full title
A Single-Blinded, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® Fibrin Sealant (Human) Compared to a Hydrogel Sealant as an Adjunct to Sutured Dural Repair
IRAS ID
173920
Contact name
Alex Green
Contact email
Sponsor organisation
Ethicon Inc.
Eudract number
2014-003954-15
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
This is a single-blinded, randomised, controlled study evaluating EVICEL® as
an adjunct to sutured dural closure when compared to a comparator product also licensed for this indication.Approximately 230 subjects undergoing posterior fossa or supratentorial procedures (craniectomy or craniotomy) will be enrolled in the trial. At least 60 subjects undergoing posterior fossa procedures will be randomised. Upon completion of the sutured dural repair, the closure will be evaluated for intraoperative cerebrospinal fluid (CSF) leakage (either spontaneous leak or following valsalva manoeuvre).
Subjects who have a CSF leak will be stratified by surgical procedure, posterior fossa or supratentorial approach, and then randomised by 1:1 allocation to either the Evicel® or comparator arm.
Subjects will be followed post-operatively through discharge and again at 30 (-/+ 7 days) days and 60 (-/+14) days post-surgery. The incidence of CSF leaks for the primary endpoint will be assessed up to the 30 day postoperative follow-up period. A CSF leak will be reported as detected by any of the following: clinical observation, diagnostic testing, imaging or the need for surgical intervention to directly treat a CSF leak.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0165
Date of REC Opinion
6 May 2015
REC opinion
Further Information Favourable Opinion