Fibrin Sealant for the Sealing of Dura Sutures

Dura Defects Clinical Trial

Official title: An Exploratory Phase 2 Study Evaluating the Efficacy and Safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent Treated (FS VH S/D) 500 S-APR for the Sealing of Dura Defect Sutures in Posterior Fossa Surgery

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dura Defects
• Pathologic Processes
• Pathological Processes in the Posterior Fossa

• NCT number: NCT00681824
• Study type: Interventional
• Source: Baxter Healthcare Corporation
• Status: Completed
• Phase: Phase 2
• Start date: May 2008
• Completion date: March 2010