Fibrin Sealant for the Sealing of Dura Sutures

Summary

The purpose of this study is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa surgery as an adjunct to dura and dura substitute sutures in preventing postoperative cerebrospinal fluid (CSF) leakage.

Timeline

Start

2008-05

Primary completion

2010-03

Completion

2010-03

Outcome

Missed primary endpoint

registry p = 0.7159; likelihood ratio of chi squared test NCT00681824 ↗

Drugs

Indications