Cerebrospinal Fluid Leaks Clinical Trial
Official title:
TachoSil® Versus Current Practice in Dura Sealing Techniques for the Prevention of Post-operative Cerebrospinal Fluid (CSF) Leaks in Patients Undergoing Skull Base Surgery: An Open Label, Randomised, Controlled, Multi-centre, Parallel Group Efficacy and Safety Trial.
The primary objective is to demonstrate superiority of TachoSil® compared to current
practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing
must be evaluated post-operatively. The secondary objective is to evaluate the safety of
TachoSil® as an adjunct in sealing the dura mater.
The trial population will consist of 726 randomised (1:1) patients elected for skull base
surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1
weeks and safety follow-up 28±2 weeks after surgery.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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