Conditions: Knee Replacement Surgery Osteoarthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 137
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: SoC: conventional hemostatic techniques such as cautery and manual compression arm 2: FLOSEAL: consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.

SoC: conventional hemostatic techniques such as cautery and manual compression

Interventions: intervention 1: Standard of Care intervention 2: FLOSEAL Hemostatic Matrix + Standard of care
Intervention descriptions: intervention 1: Conventional hemostatic techniques, such as cautery and manual compression, will be used. intervention 2: 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

Protocol document: