Status:
COMPLETED
Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Nycomed
Conditions:
Subjects Scheduled for Supra-/Infratentorial Craniotomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Main objective of this trial is to assess the hypothesis whether the application of TachoSil® as a dural sealant improves the quality of craniotomy procedure and outcome in general compared with stand...
Eligibility Criteria
Inclusion
- Neurosurgical indication for craniotomy and opening of dura to access cerebral structures/pathologies (discussed in the indication conference of board certified neurosurgeons at the University Hospital of Basel).
- The list of pathologies includes:
- primary or secondary benign/malignant brain tumors
- aneurysms
- arterious-venous malformations
- cavernomas
- pituitary adenomas
- temporal lobectomy (epilepsy surgery)
- longterm posttraumatic revisions.
Exclusion
- Presence of subdural empyema/abscess or any kind of infection affecting/infiltrating the dura mater
- Emergency for trauma
- Previous surgery on the same site
- Cases, where water-tight dural suture is not possible (intraoperative exclusion decision)
- Known hypersensitivity to TachoSil®
- Participation in another study
- Pregnancy
- Inability to read and understand the participant's information
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00999999
Start Date
October 1 2009
End Date
August 1 2012
Last Update
September 15 2015
Active Locations (1)
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1
University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031