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

June 19, 2012 updated by: Ethicon, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Evicel
Biological: Evicel
EVICEL is a human plasma derived fibrin sealant
OTHER: Sutures only
Other: Sutures only
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of success
Time Frame: Day 1 (intraoperative)
Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.
Day 1 (intraoperative)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of CSF leakage
Time Frame: Day 5 post-op
Day 5 post-op
Incidence of CSF leakage
Time Frame: Day 30 post-op
Day 30 post-op
Incidence of adverse events
Time Frame: up to 30 days post-op
up to 30 days post-op
Incidence of surgical site infections
Time Frame: Day 5 and 30 post-op
Day 5 and 30 post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon, Inc.

Collaborators

OMRIX Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (ESTIMATE)

August 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 400-09-001
  • 2009-016501-41 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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