1.
Fibrin sealant reduces perioperative blood loss in total hip replacement
Wang GJ, Goldthwaite CA, Burks S, Crawford R, Spotnitz WD, Orthopaedic Investigators Group
Journal of Long-Term Effects of Medical Implants. 2003;13((5):):399-411.
Abstract
Patients (n = 81) undergoing total hip replacement (THR) were randomized to receive either standard of care plus fibrin sealant (FS) (10 mL total) or standard of care alone to evaluate the efficacy of FS for reducing blood loss in THR. Considering the 81 intent-to-treat patients, adjusted perioperative blood loss was reduced significantly in the FS group, by 197 mL [95% CI: 45 mL, 319 mL] or 23. 5% [95% CI: 5. 4%, 38. 1%] (p = 0. 014). When protocol violators were eliminated, leaving 73 patients, the adjusted FS group perioperative bleeding was reduced by 221 mL [95% CI: 63 mL, 351 mL] or 27. 1% [95% CI: 7. 6%, 42. 5%] (p = 0. 0098).
2.
Fibrin sealant facilitates hemostasis in arteriovenous polytetrafluoroethylene grafts for renal dialysis access
Schenk WG 3rd, Goldthwaite CA Jr, Burks S, Spotnitz WD
American Surgeon. 2002;68((8):):728-32.
Abstract
A prospective randomized study was performed to evaluate the efficacy of fibrin sealant (FS) in patients undergoing upper-extremity polytetrafluoroethylene (PTFE) graft placement for dialysis. This procedure appears to be a reproducible and clinically relevant model for evaluating FS in vascular surgery. Consenting adult patients (n = 28) undergoing placement of a PTFE graft (6 mm) were randomized to either the treatment group using FS (Hemaseel APR, Haemacure Corp., Sarasota, FL) or control comparator groups (four) of bovine thrombin (T) (Thrombogen, GenTrac Inc., Middleton, WI), pressure (P), bovine thrombin (Thrombogen, GenTrac Inc.) -soaked cellulose sponges (TG) (Gelfoam, Upjohn Co., Kalamazoo, MI), or oxidized regenerated cellulose (S) (Surgicel, Johnson & Johnson, New Brunswick, NJ). All patients received heparin (3000 IU intravenous push) before placement of vascular clamps. The mean time to hemostasis was 29.3 seconds for FS, 147.4 seconds for T, 872.2 seconds for P, 346 seconds for TG, and 1044.5 seconds for S. There were no significant adverse events. FS appeared to be a superior hemostatic agent in these vascular procedures. No complications from FS were noted.