NCT01410240

Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Replacement Surgery
• Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Standard of Care	Conventional hemostatic techniques, such as cautery and manual compression, will be used.
DRUG	FLOSEAL Hemostatic Matrix + Standard of care	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

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-08-05
• Last updated: 2014-06-06
• Results posted: 2014-06-06

Locations

12 sites across 1 country: United States