Clinical trial NCT02457546: The EVICEL® Neurosurgery Phase III Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebrospinal Fluid Leak
Keywords: Fibrin sealant
CSF leak
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-29
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Intraoperatively through 30-day follow-up
Secondary outcomes:
Other outcomes:
measure: Safety Endpoint: Intra-operative CSF Leakage Follow Final Valsalva
timeFrame: Intraoperatively, after final Valsalva maneuver
Locations:
city: Los Angeles
country: United States
facility: Clinical Investigation Site #27
state: California
city: Sacramento
country: United States
facility: Clinical Investigation Site #17
state: California
city: Jacksonville
country: United States
facility: Clinical Investigation Site #18
state: Florida
city: Tampa
country: United States
facility: Clinical Investigation Site #19
state: Florida
city: Indianapolis
country: United States
facility: Clinical Investigation Site #22
state: Indiana
city: New Orleans
country: United States
facility: Clinical Investigation Site #10
state: Louisiana
city: Baltimore
country: United States
facility: Clinical Investigation Site #15
state: Maryland
city: Boston
country: United States
facility: Clinical Investigation Site #11
state: Massachusetts
city: Ann Arbor
country: United States
facility: Clinical Investigation Site #24
state: Michigan
city: New Brunswick
country: United States
facility: Clinical Investigation Site #20
state: New Jersey
city: New York
country: United States
facility: Clinical Investigation Site #12
state: New York
city: Cincinnati
country: United States
facility: Clinical Investigation Site #14
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Investigation Site #21
state: Pennsylvania
city: Sydney
country: Australia
facility: Clinical Investigation Site #51
state: New South Wales
city: Adelaide
country: Australia
facility: Clinical Investigation Site #54
state: South Australia
city: Melbourne
country: Australia
facility: Clinical Investigation Site #50
state: Victoria
city: Richmond
country: Australia
facility: Clinical Investigation Site #52
state: Victoria
city: Genk
country: Belgium
facility: Clinical Investigation Site #40
city: Leuven
country: Belgium
facility: Clinical Investigation Site #41
city: Montreal
country: Canada
facility: Clinical Investigation Site #25
state: Quebec
city: Auckland
country: New Zealand
facility: Clinical Investigation Site #53
city: London
country: United Kingdom
facility: Clinical Investigation Site #35
state: England
city: Middlesborough
country: United Kingdom
facility: Clinical Investigation Site #32
state: England
city: Nottingham
country: United Kingdom
facility: Clinical Investigation Site #35
state: England
city: Oxford
country: United Kingdom
facility: Clinical Investigation Site #30
state: England
city: Salford
country: United Kingdom
facility: Clinical Investigation Site #31
state: England
Study officials:
affiliation: Ethicon, Inc.
name: Richard Kocharian, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.