Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

PHASE4CompletedINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Knee Replacement SurgeryOsteoarthritis
Interventions
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"

Trial Locations (12)

19107

The Rothman Institute, Philadelphia, Philadelphia

19140

Temple University, Philadelphia

20037

George Washington University Medical Faculty Associates, Washington D.C.

32720

Florida Research Associates, LLC, DeLand

33316

Shrock Orthopedic Research, LLC, Fort Lauderdale

33321

Phoenix Clinical Research, LLC, Tamarac

46158

Joint Replacement Surgeons of Indiana Foundations, Mooresville

78759

Hill Country Clinical Research, Inc., Austin

80110

Colorado Orthopedic Consultants, PC, Englewood

90042

Cedars-Sinai Orthopedic Center, Los Angeles

94063

Stanford Orthopedics, Redwood City

08234-5500

Rothman Institute, Egg Harbor

All Listed Sponsors
lead

Baxter Healthcare Corporation

INDUSTRY

NCT01410240 - Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty | Biotech Hunter | Biotech Hunter