NCT00681824

Fibrin Sealant for the Sealing of Dura Sutures

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pathological Processes in the Posterior Fossa
• Dura Defects

Interventions

Type	Name	Description
BIOLOGICAL	Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)	Application of a thin layer of FS VH S/D 500 s-apr to the entire length of the suture loop and the adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes.
PROCEDURE	Standard of care	Standard care: defined as the closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-05-21
• Last updated: 2013-06-27
• Results posted: 2013-06-27

Locations

13 sites across 2 countries: United States, Canada