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 - The EVICEL® Neurosurgery Phase III Study

Ethicon, Inc.0 sites234 target enrollmentApril 1, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cerebrospinal fluid leakage in posterior fossa or supratentorial procedures (craniectomy or craniotomy) during neurosurgery
Sponsor: Ethicon, Inc.
Enrollment: 234
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

April 1, 2015

End Date

October 12, 2017

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•Pre\-Operative
•1\.Subjects \=18 years of age undergoing craniotomy/craniectomy for pathological processes in the supratentorial region or posterior fossa (such as benign or malignant tumors, vascular malformation, and Chiari 1 malformations);
•2\.Subjects or legally authorized representatives must be willing to participate in the study and provide written informed consent.
•Intra\-Operative
•1\.Surgical wound classification Class I. Superficial penetration of mastoid air cells during partial mastoidectomy is permitted.
•2\.The cuff of native dura along the craniotomy edge on each side is adequate, based on surgeon’s judgment, to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product.
•3\.Presence of intra\-operative cerebrospinal fluid (CSF) leakage following primary dural closure or after Valsalva maneuver
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Pre\-Operative
•1\.Subjects with a dural lesion from a recent surgery that still has the potential for CSF leakage.
•2\.Chemotherapy scheduled within 7 days following surgery.
•3\.Radiation therapy to the head scheduled within 7 days following surgery.
•4\.A previous craniotomy/craniectomy within 6 months prior to the study surgery.
•5\.Known hypersensitivity to the components (such as human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product.
•6\.Subjects with a known allergy to FD\&C Blue \#1 dye in DuraSeal
•7\.Subjects with an infection present at the surgical site
•8\.Subjects with an infection indicated by any one of the following: clinical diagnosis of infection, fever, positive urine culture, positive blood culture, positive chest x\-ray.
•9\.Female subjects of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period.