The EVICEL® Neurosurgery Phase III Study

January 8, 2019 updated by: Ethicon, Inc.

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2109
        • Clinical Investigation Site #51
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Clinical Investigation Site #54
    • Victoria
      • Melbourne, Victoria, Australia
        • Clinical Investigation Site #50
      • Richmond, Victoria, Australia, 3121
        • Clinical Investigation Site #52
  • Belgium
      • Genk, Belgium
        • Clinical Investigation Site #40
      • Leuven, Belgium
        • Clinical Investigation Site #41
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Clinical Investigation Site #25
  • New Zealand
      • Auckland, New Zealand, 1023
        • Clinical Investigation Site #53
  • United Kingdom
    • England
      • London, England, United Kingdom
        • Clinical Investigation Site #35
      • Middlesborough, England, United Kingdom
        • Clinical Investigation Site #32
      • Nottingham, England, United Kingdom
        • Clinical Investigation Site #35
      • Oxford, England, United Kingdom
        • Clinical Investigation Site #30
      • Salford, England, United Kingdom
        • Clinical Investigation Site #31
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Clinical Investigation Site #27
      • Sacramento, California, United States, 95817
        • Clinical Investigation Site #17
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Clinical Investigation Site #18
      • Tampa, Florida, United States, 33606
        • Clinical Investigation Site #19
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Clinical Investigation Site #22
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Clinical Investigation Site #10
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Clinical Investigation Site #15
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Clinical Investigation Site #11
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Clinical Investigation Site #24
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Clinical Investigation Site #20
    • New York
      • New York, New York, United States, 10065
        • Clinical Investigation Site #12
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Clinical Investigation Site #14
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Clinical Investigation Site #21

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

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)
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
Intraoperatively through 30-day follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Endpoint: Intra-operative CSF Leakage Follow Final Valsalva
Time Frame: Intraoperatively, after final Valsalva maneuver
Intra-operative CSF leakage follow final Valsalva
Intraoperatively, after final Valsalva maneuver

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

September 13, 2017

Study Completion (Actual)

October 12, 2017

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 29, 2015

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOS-14-002
  • 2014-003954-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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