CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 95 enrolled
Drug / intervention
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) +1 morebiological
Likely dose
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)from record
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Search/NCT00681824
NCT00681824Phase 2Completed
CompareCT.gov

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

Baxter Healthcare Corporation·interventional·Posted May 21, 2008·Updated Jun 27, 2013

In Brief

A Phase 2 clinical trial evaluating Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) and Standard of care for Pathological Processes in the Posterior Fossa and Dura Defects. Completed, enrolled 95 participants across 13 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPathological Processes in the Posterior Fossa, Dura Defects
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 21, 2008
Enrollment StartMay 1, 2008
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.1 years ago

Interventions

Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)biological

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.

Standard of careprocedure

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.