Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
Lead Sponsor:
Ethicon, Inc.
Collaborating Sponsors:
OMRIX Biopharmaceuticals
Conditions:
Dura Defects
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 clo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT01174992
Start Date
July 1 2010
End Date
October 1 2011
Last Update
June 20 2012
Active Locations (12)
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1
Department of Neurosurgery, Ziekenhuis Oost Limburg
Genk, Belgium, B-3600
2
Department of Neurosurgery, University Hospital of Liège
Liège, Belgium, B-4000
3
Department of Neurosciences and Rehabilitation, Tampere University Hospital
Tampere, Finland, FI-33521
4
Service de Neurochirurgie B, Hopital Neurologique de Lyon
Cedex, France, 696 BRON