The Paediatric EVICEL® Neuro Study

NCT02309645 | Terminated Phase 3 Results

• 2 other identifiers: BIOS-13-0062013-003558-26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of EVICEL® when used for suture-line sealing in dura-mater closure in elective or urgent paediatric cranial neurosurgery to provide intraoperative watertight closure.

Conditions

CSF Leak

Keywords

fibrin sealant; CSF leak

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Success (Intraoperative Watertight Closure) in the Treatment of Intraoperative Cerebrospinal Fluid (CSF) Leakage

  Percentage of participants with success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage were reported. Success is defined as no CSF leakage from dural repair intraoperatively, during Valsalva Maneuver 20-25 centimeters (cm) water (H2O) for 5-10 seconds.

  Intraoperative (up to 1 day)

Secondary Outcomes (4)

• Number of Participants Experiencing CSF Leakage Within 7 Days Post-operatively

  Up to 7 days post-operatively

• Number of Participants Experiencing CSF Leakage Within 33 Days Post-operatively

  Up to 33 days post-operatively

• Number of Participants With Adverse Events (AEs)

  Up to 33 days

• Number of Participants With Surgical Site Infections (SSI) According to National Healthcare Safety Network (NHSN) Criteria Within 33 Days Post-operatively

  Up to 33 days

Study Arms (2)

EVICEL® Fibrin Sealant

EXPERIMENTAL

EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product

Biological: EVICEL® Fibrin Sealant

Sutures Only

OTHER

Subjects randomized to control will receive additional dural repair sutures as deemed necessary by the surgeon to attempt to achieve a watertight closure.

Other: Sutures Only

Interventions

EVICEL® Fibrin Sealant BIOLOGICAL

Subjects randomized to receive EVICEL® Fibrin Sealant (Human), a thin layer will be applied to the entire length of the suture line and the adjacent area to at least 5mm away, including all suture holes.

Also known as: EVICEL, fibrin sealant

EVICEL® Fibrin Sealant

Sutures Only OTHER

Subjects randomized to Control (Additional Sutures) will receive additional dural repair sutures applied immediately to the dural suture line after randomization as deemed necessary by the surgeon.

Sutures Only

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient undergoing elective or urgent craniotomy/craniectomy for pathological processes in the posterior fossa (such as benign or malignant tumors, vascular malformation, and Chiari 1 malformations) or in the supratentorial region and who are demonstrated to have persistent CSF leakage following primary attempt at suture closure of the dural incision;
• Administration of perioperative antibiotic prophylaxis;
• Patients who are less than 18 years of age;
• Patients who are able and willing to comply with the procedures required by the protocol;
• The subject's parent/legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. In addition, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial.
• Surgical wound classification Class I (refer to Appendix II). Penetration of mastoid air cells during partial mastoidectomy is permitted;
• The cuff of native dura along the craniotomy edge on each side is wide enough based on surgeon's judgment to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product.

You may not qualify if:

• Subjects with a dura lesion from a recent surgery that still has the potential for CSF leakage;
• Conditions or treatments significantly compromising the immune system (such as AIDS);
• Known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product;
• Hydrocephalus, except occlusive hydrocephalus caused by posterior fossa pathology to be treated.
• Existing CSF (ventricular, etc.) drains, shunts, Cushing/Dandy cannulation or Burr holes which damage the dura;
• Female subjects of childbearing potential with a positive urine or serum pregnancy test within 24 hours prior to surgery;
• Female subjects who are breastfeeding or intend to become pregnant during the clinical study period;
• Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment or expected during the study period;
• Scheduled or foreseeable surgery within the follow-up period.
• Dura injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dura cuff;
• Use of implants made of synthetic materials coming into direct contact with dura (e.g., PTFE patches, shunts, ventricular and subdural drains);
• Planned use of dural patches after primary suture closure of the dura;
• Placement of Gliadel Wafers;
• Persistent signs of increased brain turgor;
• Patient has a gap between durotomy edges of greater than 2mm after primary dural closure.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (7)

Clinical Investigation Site #24

Edinburgh, United Kingdom

Location

Clinical Investigation Site #22

Leeds, United Kingdom

Location

Clinical Investigation Site #21

Liverpool, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Clinical Investigation Site #25

London, United Kingdom

Location

Clinical Investigation Site #23

Manchester, United Kingdom

Location

Clinical Investigation Site #20

Oxford, United Kingdom

Location

Related Publications (1)

• Sivakumar G, Magdum S, Aquilina K, Kandasamy J, Josan V, Ilie B, Barnett E, Kocharian R, Pettorini B. Safety and effectiveness of Evicel(R) fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery. Childs Nerv Syst. 2024 Sep;40(9):2735-2745. doi: 10.1007/s00381-024-06434-4. Epub 2024 May 10.

  PMID: 38727726 DERIVED

MeSH Terms

Conditions

Cerebrospinal Fluid Otorrhea

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid Leak; 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: Senior Franchise Medical Director
• Organization: Ethicon Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Richard Kocharian, MD, PhD

  Ethicon, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: December 5, 2014
• Study Start: October 1, 2014
• Primary Completion: August 17, 2021
• Study Completion: September 17, 2021
• Last Updated: July 14, 2023
• Results First Posted: July 14, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (7)