Potent Hemostatic Efficacy of a Novel Recombinant Fibrin Sealant Patch (KTF-374) in Rabbit Bleeding Models.

ABSTRACT

PURPOSE: Fibrin sealants are used for hemostasis during surgery. Commercially available fibrin sealants are made of materials of human or animal origin. We developed a novel recombinant fibrin sealant patch (KTF-374) that has thin and flexible properties. This study evaluated the hemostatic efficacy of KTF-374 for various patterns of bleeding in rabbits, as compared with that of the existing fibrin-coated collagen fleece (FCCF). MATERIALS AND METHODS: Test hemostats used were KTF-374 and FCCF. Laparotomy was performed under general anesthesia in rabbits. We created wounds in the liver, caudal vena cava, and ventral aorta under anticoagulating conditions with heparin. Test hemostats were then applied to the wound site and compressed manually for 3 min. Hemostatic efficacy was evaluated with the success rate of hemostasis at 3 min. RESULTS: In all bleeding models, the success rate of hemostasis was significantly higher with KTF-374 than FCCF. The hemostatic success rate of KTF-374 and FCCF was 100% vs. 25% (p = .007) in the partial hepatectomy model (n = 8); 100% vs. 12.5% (p = .001) in the caudal vena cava resection model (n = 8); and 100% vs. 25% (p = .004) in the ventral aortic puncture model (n = 8). The wound site could clearly be recognized through the patch after the application of KTF-374 but not FCCF. CONCLUSIONS: These results suggest that KTF-374 possesses more potent hemostatic properties than FCCF for various patterns of bleeding. KTF-374 is a promising hemostat due to its potent efficacy and good visibility of the wound site through the patch.