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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

September 30, 2011

Study Completion Date

October 31, 2011

Conditions
Dura Defects
Interventions
BIOLOGICAL

Evicel

EVICEL is a human plasma derived fibrin sealant

OTHER

Sutures only

Standard of care

Trial Locations (12)

35385

Department of Neurosurgery, University Giessen-Marburg, Giessen

85049

Department of Neurosurgery, Klinikum Ingolstadt GmbH, Ingolstadt

B-3600

Department of Neurosurgery, Ziekenhuis Oost Limburg, Genk

B-4000

Department of Neurosurgery, University Hospital of Liège, Liège

FI-33521

Department of Neurosciences and Rehabilitation, Tampere University Hospital, Tampere

696 BRON

Service de Neurochirurgie B, Hopital Neurologique de Lyon, Cedex

D-45122

Klinik für Neurochirurgie, Universitätsklinikum Essen, Essen

D-24105

Department of Neurosurgery University Clinics of Schleswig-Holstein Campus Kiel, Kiel

1081 HV

VU Medical Centre, Amsterdam

OX3 9DU

Department of Neurosurgery, John Radcliffe Hospital, Headington

DD1 9SY

Department of Neurosurgery, Ninewells Hospital & Medical School, Dundee

EH4 2XU

Edinburgh Centre for Neuro-Oncology, Western General Hospital, Edinburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

OMRIX Biopharmaceuticals

INDUSTRY

lead

Ethicon, Inc.

INDUSTRY

NCT01174992 - A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair | Biotech Hunter | Biotech Hunter