The EVICEL® Neurosurgery Phase III Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02457546
• Date of registration: 27/05/2015
• Prospective Registration: Yes
• Primary sponsor: Ethicon, Inc.
• Public title: The EVICEL® Neurosurgery Phase III Study
• Scientific 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
• Date of first enrolment: July 1, 2015
• Target sample size: 234
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02457546
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Richard Kocharian, MD, PhD
• Affiliation: Ethicon, Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cerebrospinal Fluid Leak

Intervention(s)

Biological: EVICEL Fibrin Sealant

Device: Hydrogel sealant

Primary Outcome(s)

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]

Secondary ID(s)

2014-003954-15

BIOS-14-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02457546