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The EVICEL® Neurosurgery Phase III Study

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Ethicon, Inc.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT02457546
First received: May 27, 2015
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Cerebrospinal Fluid Leak Biological: EVICEL Fibrin Sealant Device: Hydrogel sealant Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • The primary endpoint is the proportion of subjects that do not have a CSF leak during surgery and up to the 30-day post-operative period. [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Incidence of Intra-operative CSF leakage following final Valsalva maneuver [ Time Frame: Intraoperative ]
  • Incidence of post-operative CSF leakage within 30 days post-operatively. [ Time Frame: 30 days ]
  • Incidence of post-operative CSF leakage within 60 days post-operatively. [ Time Frame: 60 days ]
  • Incidence of adverse events [ Time Frame: 60 days ]
  • Incidence of surgical site infections within 30 days post-operatively [ Time Frame: 30 days ]

Estimated Enrollment: 230
Actual Study Start Date: July 1, 2015
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: June 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EVICEL Fibrin Sealant
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
Biological: EVICEL Fibrin Sealant
Other Name: fibrin sealant
Active Comparator: Hydrogel sealant
The sealant is composed of two solutions, a polyethylene glycol (PEG) ester solution and a trilysine amine solution
Device: Hydrogel sealant

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02457546

Contacts
Contact: Leonie Rynn, MD 908-218-2492 LRynn1@its.jnj.com

  Show 28 Study Locations
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Richard Kocharian, MD, PhD Ethicon, Inc.
  More Information

Publications:
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT02457546     History of Changes
Other Study ID Numbers: BIOS-14-002
2014-003954-15 ( EudraCT Number )
Study First Received: May 27, 2015
Last Updated: May 2, 2017

Keywords provided by Ethicon, Inc.:
Fibrin sealant
CSF leak

Additional relevant MeSH terms:
Cerebrospinal Fluid Leak
Cerebrospinal Fluid Rhinorrhea
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries
Fibrin Tissue Adhesive
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on June 26, 2017