A study to evaluate the safety and effectiveness of EVICEL® Fibrin sealant (Human) as compared to Hydrogel sealant in the repair of the dura in addition to sutures.

Phase 1

Conditions: Cerebrospinal fluid leakage in posterior fossa or supratentorial procedures (craniectomy or craniotomy) during neurosurgery
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2014-003954-15-BE

Lead Sponsor: Ethicon, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 230

Inclusion Criteria

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
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Pre-Operative
1.Subjects with a dural lesion from a recent surgery that still has the potential for CSF leakage.
2.Chemotherapy within 30-days prior to enrooment or scheduled within 7 days following surgery.
3.Radiation therapy to the head within 30 days prior to enrollment of 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.
10.Female subjects who are nursing.
11.Exposure to another investigational drug or device clinical trial within 30 days prior to enrollment or anticipated in the 60 day follow-up period.
12.Subjects with severely altered renal or hepatic function, with a compromised immune system or autoimmune disease who can NOT receive DuraSeal™.
13.Subjects with penetrating traumatic injuries to the head with damage to the dura.

Intra-Operative
1.Dural injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dural cuff.
2.Patient has a gap between durotomy edges of greater than 2mm after primary dural closure.
3.Approaches that would not allow sutured dural closure such as trans-sphenoidal or trans-labirinthine-/petrosal/-mastoid. Superficial penetration mastoid air cells are allowed.
4.Use of implants made of synthetic materials coming into direct contact with dura (e.g., PTFE patches, shunts, ventricular and subdural drains, exisisting CSF drains on the surgical path).
5.Use of other fibrin sealants or PEG-based sealants on the dural closure. Approved fibrin sealants may be used for hemostasis if not in contact with the dura.
6.Hydrocephalus, except occlusive hydrocephalus caused by posterior fossa pathology or incompletely open cerebrospinal fluid pathways, to be treated during surgical procedure.
7.Placement of Gliadel Wafers
8.Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dural resection.
9.Two or more separate dural defect, including defects from ventricular cannulation and ventriculo-peritoneal shunting.
10.Subjects with any other intra-operative findings identified by the surgeon that may preclude the conduct of the study procedure.
11.Confined bony structures where nerves are present where neural compression may result due to swelling.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant (Human) for use as an adjunct to sutured dural repair in cranial surgery;Secondary Objective: Not applicable;Primary end point(s): The proportion of subjects that do not have a CSF leak during surgery and up to the 30 day (± 7) post operative period. ;Timepoint(s) of evaluation of this end point: Starting from randomization and up to the 30 day (± 7) post operative period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Incidence of Intra operative CSF leakage following final Valsalva maneuver.<br>2. Incidence of post operative CSF leakage within 30 (±7) days postoperatively.<br>3. Incidence of post operative CSF leakage within 60 (± 14) days postoperatively.<br>4. Incidence of adverse events.<br>5. Incidence of surgical site infections (SSI) according to NNIS definition and CDC classification within 30 days (±7) post operatively.;Timepoint(s) of evaluation of this end point: From surgery up to the 60 day (± 14) post operative period.

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