A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair

Phase 2

Completed

• Conditions: Dura Defects
• Interventions: Biological: Evicel; Other: Sutures only

• Registration Number: NCT01174992
• Lead Sponsor: Ethicon, Inc.

Brief Summary

The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.

Detailed Description

This is a randomized, multi-center controlled study evaluating the effectiveness of EVICEL\* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-04
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• Patient undergoing elective craniotomy/craniectomy
• Age greater than or equal to 18 years
• Patients who are able and willing to comply with the procedures required by the protocol.
• Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures.

Exclusion Criteria

• Chemotherapy or radiation therapy within 7 days following surgery.
• Conditions compromising the immune system.
• 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.
• Female subjects of childbearing potential with a positive pregnancy test 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.
• Major intraoperative findings or complications identified by the surgeon that may preclude conduct of the planned surgical procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evicel	Evicel	-
Sutures only	Sutures only	-

Primary Outcome Measures

Name	Time	Method
Proportion of success	Day 1 (intraoperative)	Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.

Secondary Outcome Measures

Name	Time	Method
Incidence of CSF leakage	Day 30 post-op
Incidence of adverse events	up to 30 days post-op
Incidence of surgical site infections	Day 5 and 30 post-op

Trial Locations

Locations (12)

VU Medical Centre; 🇳🇱 Amsterdam, Netherlands

Department of Neurosurgery, Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium

Department of Neurosurgery, University Hospital of Liège; 🇧🇪 Liège, Belgium

Department of Neurosurgery, University Giessen-Marburg; 🇩🇪 Giessen, Germany

Service de Neurochirurgie B, Hopital Neurologique de Lyon; 🇫🇷 Cedex, France

Klinik für Neurochirurgie, Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Department of Neurosciences and Rehabilitation, Tampere University Hospital; 🇫🇮 Tampere, Finland

Department of Neurosurgery, Klinikum Ingolstadt GmbH; 🇩🇪 Ingolstadt, Germany

Department of Neurosurgery, John Radcliffe Hospital; 🇬🇧 Headington, Oxford, United Kingdom

Department of Neurosurgery University Clinics of Schleswig-Holstein Campus Kiel; 🇩🇪 Kiel, Germany

Edinburgh Centre for Neuro-Oncology, Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

Department of Neurosurgery, Ninewells Hospital & Medical School; 🇬🇧 Dundee, United Kingdom