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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01174992
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : June 20, 2012
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dura Defects Biological: Evicel Other: Sutures only Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Evicel Biological: Evicel
EVICEL is a human plasma derived fibrin sealant

Sutures only Other: Sutures only
Standard of care

Primary Outcome Measures :
  1. Proportion of success [ Time Frame: Day 1 (intraoperative) ]
    Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.

Secondary Outcome Measures :
  1. Incidence of CSF leakage [ Time Frame: Day 5 post-op ]
  2. Incidence of CSF leakage [ Time Frame: Day 30 post-op ]
  3. Incidence of adverse events [ Time Frame: up to 30 days post-op ]
  4. Incidence of surgical site infections [ Time Frame: Day 5 and 30 post-op ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01174992

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Department of Neurosurgery, Ziekenhuis Oost Limburg
Genk, Belgium, B-3600
Department of Neurosurgery, University Hospital of Liège
Liège, Belgium, B-4000
Department of Neurosciences and Rehabilitation, Tampere University Hospital
Tampere, Finland, FI-33521
Service de Neurochirurgie B, Hopital Neurologique de Lyon
Cedex, France, 696 BRON
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
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
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Study Director: James Hart, MD Ethicon, Inc.

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Responsible Party: Ethicon, Inc. Identifier: NCT01174992     History of Changes
Other Study ID Numbers: 400-09-001
2009-016501-41 ( EudraCT Number )
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012

Keywords provided by Ethicon, Inc.:
Fibrin sealant
CSF leak