The EVICEL® Neurosurgery Phase III Study

NCT02457546 | Completed Phase 3 Results

• 2 other identifiers: BIOS-14-0022014-003954-15
• Study Type: interventional
• Target: 234
• Locations: 6 countries
• Sites: 26

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.

Conditions

Cerebrospinal Fluid Leak

Keywords

Fibrin sealant; CSF leak

Outcome Measures

Primary Outcomes (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)

  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 Outcomes (1)

• Safety Endpoint: Intra-operative CSF Leakage Follow Final Valsalva

  Intraoperatively, after final Valsalva maneuver

Study Arms (2)

EVICEL Fibrin Sealant

EXPERIMENTAL

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

Biological: EVICEL Fibrin Sealant

Hydrogel sealant

ACTIVE COMPARATOR

The sealant is composed of two solutions, a polyethylene glycol (PEG) ester solution and a trilysine amine solution

Device: Hydrogel sealant

Interventions

EVICEL Fibrin Sealant BIOLOGICAL

Also known as: fibrin sealant

EVICEL Fibrin Sealant

Hydrogel sealant DEVICE

Hydrogel sealant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (26)

Clinical Investigation Site #27

Los Angeles, California, 90033, United States

Location

Clinical Investigation Site #17

Sacramento, California, 95817, United States

Location

Clinical Investigation Site #18

Jacksonville, Florida, 32207, United States

Location

Clinical Investigation Site #19

Tampa, Florida, 33606, United States

Location

Clinical Investigation Site #22

Indianapolis, Indiana, 46202, United States

Location

Clinical Investigation Site #10

New Orleans, Louisiana, 70121, United States

Location

Clinical Investigation Site #15

Baltimore, Maryland, 21201, United States

Location

Clinical Investigation Site #11

Boston, Massachusetts, 02215, United States

Location

Clinical Investigation Site #24

Ann Arbor, Michigan, 48109, United States

Location

Clinical Investigation Site #20

New Brunswick, New Jersey, 08903, United States

Location

Clinical Investigation Site #12

New York, New York, 10065, United States

Location

Clinical Investigation Site #14

Cincinnati, Ohio, 45219, United States

Location

Clinical Investigation Site #21

Philadelphia, Pennsylvania, 19107, United States

Location

Clinical Investigation Site #51

Sydney, New South Wales, 2109, Australia

Location

Clinical Investigation Site #54

Adelaide, South Australia, 5000, Australia

Location

Clinical Investigation Site #50

Melbourne, Victoria, Australia

Location

Clinical Investigation Site #52

Richmond, Victoria, 3121, Australia

Location

Clinical Investigation Site #40

Genk, Belgium

Location

Clinical Investigation Site #41

Leuven, Belgium

Location

Clinical Investigation Site #25

Montreal, Quebec, H3A 2B4, Canada

Location

Clinical Investigation Site #53

Auckland, 1023, New Zealand

Location

Clinical Investigation Site #35

London, England, United Kingdom

Location

Clinical Investigation Site #32

Middlesbrough, England, United Kingdom

Location

Clinical Investigation Site #35

Nottingham, England, United Kingdom

Location

Clinical Investigation Site #30

Oxford, England, United Kingdom

Location

Clinical Investigation Site #31

Salford, England, United Kingdom

Location

Related Publications (1)

• Green AL, Arnaud A, Batiller J, Eljamel S, Gauld J, Jones P, Martin D, Mehdorn M, Ohman J, Weyns F. A multicentre, prospective, randomized, controlled study to evaluate the use of a fibrin sealant as an adjunct to sutured dural repair. Br J Neurosurg. 2015 Feb;29(1):11-17. doi: 10.3109/02688697.2014.948808. Epub 2014 Aug 12.

  PMID: 25112563 BACKGROUND

MeSH Terms

Conditions

Cerebrospinal Fluid Leak; Cerebrospinal Fluid Otorrhea

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Richard Kocharian, MD, PhD
• Organization: Ethicon, Inc.

rkochar1@its.jnj.com

1-908-218-2013

Study Officials

• Richard Kocharian, MD, PhD

  Ethicon, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: May 29, 2015
• Study Start: July 1, 2015
• Primary Completion: September 13, 2017
• Study Completion: October 12, 2017
• Last Updated: January 10, 2019
• Results First Posted: December 4, 2018

Record last verified: 2019-01

Locations

US (13); GB (5); AU (4); BE (2); CA (1); NZ (1)