The EVICEL® Neurosurgery Phase III Study

Cerebrospinal Fluid Leak Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457546
• Other study ID #: BIOS-14-002
• Secondary ID: 2014-003954-15
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2015
• Est. completion date: October 12, 2017

Study information

• Verified date: January 2019
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: October 12, 2017
• Est. primary completion date: September 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak

Intervention

Biological:
• EVICEL Fibrin Sealant

Device:
• Hydrogel sealant

Locations

Country	Name	City	State
Australia	Clinical Investigation Site #54	Adelaide	South Australia
Australia	Clinical Investigation Site #50	Melbourne	Victoria
Australia	Clinical Investigation Site #52	Richmond	Victoria
Australia	Clinical Investigation Site #51	Sydney	New South Wales
Belgium	Clinical Investigation Site #40	Genk
Belgium	Clinical Investigation Site #41	Leuven
Canada	Clinical Investigation Site #25	Montreal	Quebec
New Zealand	Clinical Investigation Site #53	Auckland
United Kingdom	Clinical Investigation Site #35	London	England
United Kingdom	Clinical Investigation Site #32	Middlesborough	England
United Kingdom	Clinical Investigation Site #35	Nottingham	England
United Kingdom	Clinical Investigation Site #30	Oxford	England
United Kingdom	Clinical Investigation Site #31	Salford	England
United States	Clinical Investigation Site #24	Ann Arbor	Michigan
United States	Clinical Investigation Site #15	Baltimore	Maryland
United States	Clinical Investigation Site #11	Boston	Massachusetts
United States	Clinical Investigation Site #14	Cincinnati	Ohio
United States	Clinical Investigation Site #22	Indianapolis	Indiana
United States	Clinical Investigation Site #18	Jacksonville	Florida
United States	Clinical Investigation Site #27	Los Angeles	California
United States	Clinical Investigation Site #20	New Brunswick	New Jersey
United States	Clinical Investigation Site #10	New Orleans	Louisiana
United States	Clinical Investigation Site #12	New York	New York
United States	Clinical Investigation Site #21	Philadelphia	Pennsylvania
United States	Clinical Investigation Site #17	Sacramento	California
United States	Clinical Investigation Site #19	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  New Zealand,  United Kingdom, 

References & 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. 2014 Aug 12:1-7. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Endpoint: Intra-operative CSF Leakage Follow Final Valsalva	Intra-operative CSF leakage follow final Valsalva	Intraoperatively, after final Valsalva maneuver
Primary	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