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

This study has been completed.
Sponsor:
Collaborator:
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01174992
First received: August 3, 2010
Last updated: June 19, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 20, 2014