The EVICEL® Neurosurgery Phase III Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cerebrospinal Fluid Leak

Intervention / Treatment
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* Biological: EVICEL Fibrin Sealant
* Device: Hydrogel sealant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥18 years of age undergoing craniotomy/craniectomy for pathological processes in the supratentorial region or posterior fossa Subjects or legally authorized representatives must be willing to participate in the study and provide written informed consent. Surgical wound classification Class I 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 Presence of intra-operative cerebrospinal fluid (CSF) leakage following primary dural closure or after Valsalva maneuver Exclusion Criteria: Subjects with a dural lesion from a recent surgery that still has the potential for CSF leakage. Chemotherapy within 30-days prior to enrollment or scheduled within 7-days following surgery Radiation therapy to the head within 30-days prior to enrollment or scheduled within 7-days following surgery A previous craniotomy/craniectomy within 6 months prior to the study surgery. Known hypersensitivity to the components of the investigational product. Subjects with a known allergy to FD&C Blue #1 dye Subjects with an infection present at the surgical site 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. Female subjects of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period. Female subjects who are nursing. Exposure to another investigational drug or device clinical trial within 30 days prior to enrollment or anticipated in the 60 day follow-up period. Subjects with severely altered renal or hepatic function, with a compromised immune system or autoimmune disease who can NOT receive hydrogel sealant. Subjects with penetratring traumatic injuries to the head with damage to the dura Dural injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dural cuff. Patient has a gap between durotomy edges of greater than 2mm after primary dural closure. Approaches that would not allow sutured dural closure such as trans-sphenoidal or trans-labirinthine-/petrosal/-mastoid. Superficial penetration of mastoid air cells are allowed. Use of implants made of synthetic materials coming into direct contact with dura 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. Hydrocephalus, except occlusive hydrocephalus caused by posterior fossa pathology or incompletely open cerebrospinal fluid pathways, to be treated during surgical procedure. Placement of Gliadel Wafers Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dural resection. Two or more separate cranial dural defects, including defects from ventricular cannulation and ventriculo-peritoneal shunting. Subjects with any other intra-operative findings identified by the surgeon that may preclude the conduct of the study procedure. Confined bony structures where nerves are present where neural compression may result due to swelling.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVICEL Fibrin Sealant<br>EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen | Biological: EVICEL Fibrin Sealant<br> <br> * Other names: fibrin sealant;|
| Active Comparator: Hydrogel sealant<br>The sealant is composed of two solutions, a polyethylene glycol (PEG) ester solution and a trilysine amine solution | Device: Hydrogel sealant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or Pseudomeningocele in the Surgical Area During the 30-day Follow-up Period) | The primary endpoint was the proportion of subjects that had no inter-operative CSF leak following Valsalva maneuver and no CSF leak or pseudomeningocele in the surgical area during the 30-day follow-up period | Intraoperatively through 30-day follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrin sealant, CSF leak