At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Controlled, Single-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of FLOSEAL for Hemostasis in Primary Unilateral Total Knee Arthroplasty (TKA)
In Brief
A Phase 4 clinical trial evaluating Standard of Care and FLOSEAL Hemostatic Matrix + Standard of care for Knee Replacement Surgery and Osteoarthritis. Completed, enrolled 137 participants across 12 sites.
Detailed Summary
The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty.
Study Details
Timeline
Interventions
Conventional hemostatic techniques, such as cautery and manual compression, will be used.
FLOSEAL will be applied topically to areas of the knee where bleeding is observed (e.g. cut bone surfaces, subcutaneous tissue, posterior joint capsule, synovial tissue, medial and lateral gutters, branches of the genicular vessels, and suprapatellar pouch) and will occur intraoperatively. Sufficient amounts of FLOSEAL will be applied quickly using the provided applicators, followed by immediate approximation with a damp gauze, lap pad or sponge for approximately 2 minutes. \+ Standard of care: conventional hemostatic techniques, such as cautery and manual compression, will be used