BioSurgery Advancing Surgery, Enhancing Life

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Controlled Prospective Clinical Trial1,2
N=309; Cardiovascular/Vascular/Spinal-Orthopedic Surgery

309 patients were randomized after bleeding was identified to FLOSEAL or bovine thrombin soaked gelatin sponge (Control) groups. Success was defined as hemostasis within 10 minutes and bleeding was checked at 1, 2, 3, 6 and 10 minutes1 Bleeding was rated as "oozing," "flowing" or "pulsatile," with approximately one-third of the patients falling into the latter two categories.

Percent Stopped Bleeding 

*Per protocol analysis; (6) patients, 3 in the FLOSEAL group and 3 in the control group, were excluded because of protocol deviations in measuring hemostasis for the first treated bleeding site.  When the data were stratified by surgical specialty, the median times to hemostasis were shorter for the FLOSEAL group than for the control group in all specialties.

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EFFICACY3

FLOSEAL'S Hemostasis Success at 10 Minutes by Severity of Bleeding (First Treated Bleeding Site)

Control = Thrombin & Gelfoam , N=146 cardiac surgery patients

Efficacy (10 minutes)

Summary: FLOSEAL performed significantly better than Gelfoam- Thrombin in both the oozing and heavy bleeding categories.3


    References:

  1. FLOSEAL [Hemostatic Matrix] Instructions for Use, 03/2005. 
  2. Renkens Jr K.L., et al. A Multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery.  Spine 2001; 26:1645-1650. 
  3. Oz M.Cc, Cosgrove III D.M., Badduke B.R., Hill J.D., Flannery M.R., Palumbo R, Topic N, and the Fusion Matrix Study Group. Controlled Clinical Trial of a Novel Hemostatic Agent in Cardiac Surgery. Ann Thorac Surg. 2000, 69(5): 1376-1382.