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

Purpose

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.

Condition	Intervention	Phase
Dura Defects	Biological: Evicel Other: Sutures only	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:

Proportion of success [ Time Frame: Day 1 (intraoperative) ] [ Designated as safety issue: Yes ]
Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.

Secondary Outcome Measures:

Incidence of CSF leakage [ Time Frame: Day 5 post-op ] [ Designated as safety issue: Yes ]
Incidence of CSF leakage [ Time Frame: Day 30 post-op ] [ Designated as safety issue: Yes ]
Incidence of adverse events [ Time Frame: up to 30 days post-op ] [ Designated as safety issue: Yes ]
Incidence of surgical site infections [ Time Frame: Day 5 and 30 post-op ] [ Designated as safety issue: Yes ]

Enrollment:	139
Study Start Date:	July 2010
Study Completion Date:	October 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Evicel	Biological: Evicel EVICEL is a human plasma derived fibrin sealant
Sutures only	Other: Sutures only Standard of care

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174992

Locations

Belgium
Department of Neurosurgery, Ziekenhuis Oost Limburg
Genk, Belgium, B-3600
Department of Neurosurgery, University Hospital of Liège
Liège, Belgium, B-4000
Finland
Department of Neurosciences and Rehabilitation, Tampere University Hospital
Tampere, Finland, FI-33521
France
Service de Neurochirurgie B, Hopital Neurologique de Lyon
Cedex, France, 696 BRON
Germany
Klinik für Neurochirurgie, Universitätsklinikum Essen
Essen, Germany, D-45122
Department of Neurosurgery, University Giessen-Marburg
Giessen, Germany, 35385
Department of Neurosurgery, Klinikum Ingolstadt GmbH
Ingolstadt, Germany, 85049
Department of Neurosurgery University Clinics of Schleswig-Holstein Campus Kiel
Kiel, Germany, D-24105
Netherlands
VU Medical Centre
Amsterdam, Netherlands, 1081 HV
United Kingdom
Department of Neurosurgery, John Radcliffe Hospital
Headington, Oxford, United Kingdom, OX3 9DU
Department of Neurosurgery, Ninewells Hospital & Medical School
Dundee, United Kingdom, DD1 9SY
Edinburgh Centre for Neuro-Oncology, Western General Hospital
Edinburgh, United Kingdom, EH4 2XU

Sponsors and Collaborators

Ethicon, Inc.

OMRIX Biopharmaceuticals

Investigators

Study Director:

James Hart, MD

Ethicon, Inc.

More Information

No publications provided

Responsible Party:	Ethicon, Inc.
ClinicalTrials.gov Identifier:	NCT01174992 History of Changes
Other Study ID Numbers:	400-09-001, 2009-016501-41
Study First Received:	August 3, 2010
Last Updated:	June 19, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Paul-Ehrlich-Institut Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Ethicon, Inc.:

Fibrin sealant
CSF leak

Additional relevant MeSH terms:

Fibrin Tissue Adhesive
Hemostatics
Coagulants

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013