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The EVICEL® Neurosurgery Phase III Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02457546
Recruitment Status : Completed
First Posted : May 29, 2015
Results First Posted : December 4, 2018
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
Ethicon, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Cerebrospinal Fluid Leak Biological: EVICEL Fibrin Sealant Device: Hydrogel sealant Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : September 13, 2017
Actual Study Completion Date : October 12, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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) [ Time Frame: Intraoperatively through 30-day follow-up ]
    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

Other Outcome Measures:
  1. Safety Endpoint: Intra-operative CSF Leakage Follow Final Valsalva [ Time Frame: Intraoperatively, after final Valsalva maneuver ]
    Intra-operative CSF leakage follow final Valsalva

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02457546

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Sponsors and Collaborators
Ethicon, Inc.
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Study Director: Richard Kocharian, MD, PhD Ethicon, Inc.
  Study Documents (Full-Text)

Documents provided by Ethicon, Inc.:
Statistical Analysis Plan  [PDF] March 21, 2016
Study Protocol  [PDF] May 16, 2016

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Responsible Party: Ethicon, Inc. Identifier: NCT02457546    
Other Study ID Numbers: BIOS-14-002
2014-003954-15 ( EudraCT Number )
First Posted: May 29, 2015    Key Record Dates
Results First Posted: December 4, 2018
Last Update Posted: January 10, 2019
Last Verified: January 2019
Keywords provided by Ethicon, Inc.:
Fibrin sealant
CSF leak
Additional relevant MeSH terms:
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Cerebrospinal Fluid Leak
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Fibrin Tissue Adhesive