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

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...

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Main Authors: Sumika Miyabashira (Tanaka), Takayuki Imamura, Miho Fujimoto, Akitoshi Ohno, Tsunefumi Kobayashi, Noriko Shinya
Format: Article
Language:English
Published: Taylor & Francis Group 2019-04-01
Series:Journal of Investigative Surgery
Subjects:
Online Access:http://dx.doi.org/10.1080/08941939.2017.1398789
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author Sumika Miyabashira (Tanaka)
Takayuki Imamura
Miho Fujimoto
Akitoshi Ohno
Tsunefumi Kobayashi
Noriko Shinya
author_facet Sumika Miyabashira (Tanaka)
Takayuki Imamura
Miho Fujimoto
Akitoshi Ohno
Tsunefumi Kobayashi
Noriko Shinya
author_sort Sumika Miyabashira (Tanaka)
collection DOAJ
description 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.
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spelling doaj.art-f9985ad316e74a3f9b0ba954316736f22023-09-15T10:12:28ZengTaylor & Francis GroupJournal of Investigative Surgery0894-19391521-05532019-04-0132325726110.1080/08941939.2017.13987891398789Potent Hemostatic Efficacy of a Novel Recombinant Fibrin Sealant Patch (KTF-374) in Rabbit Bleeding ModelsSumika Miyabashira (Tanaka)0Takayuki Imamura1Miho Fujimoto2Akitoshi Ohno3Tsunefumi Kobayashi4Noriko Shinya5The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)Teijin Institute for Bio-medical Research, Teijin Pharma LimitedTeijin Institute for Bio-medical Research, Teijin Pharma LimitedThe Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)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.http://dx.doi.org/10.1080/08941939.2017.1398789fibrin sealantshemostatrabbit bleeding modelsrecombinant fibrinogen/thrombin patch
spellingShingle Sumika Miyabashira (Tanaka)
Takayuki Imamura
Miho Fujimoto
Akitoshi Ohno
Tsunefumi Kobayashi
Noriko Shinya
Potent Hemostatic Efficacy of a Novel Recombinant Fibrin Sealant Patch (KTF-374) in Rabbit Bleeding Models
Journal of Investigative Surgery
fibrin sealants
hemostat
rabbit bleeding models
recombinant fibrinogen/thrombin patch
title Potent Hemostatic Efficacy of a Novel Recombinant Fibrin Sealant Patch (KTF-374) in Rabbit Bleeding Models
title_full Potent Hemostatic Efficacy of a Novel Recombinant Fibrin Sealant Patch (KTF-374) in Rabbit Bleeding Models
title_fullStr Potent Hemostatic Efficacy of a Novel Recombinant Fibrin Sealant Patch (KTF-374) in Rabbit Bleeding Models
title_full_unstemmed Potent Hemostatic Efficacy of a Novel Recombinant Fibrin Sealant Patch (KTF-374) in Rabbit Bleeding Models
title_short Potent Hemostatic Efficacy of a Novel Recombinant Fibrin Sealant Patch (KTF-374) in Rabbit Bleeding Models
title_sort potent hemostatic efficacy of a novel recombinant fibrin sealant patch ktf 374 in rabbit bleeding models
topic fibrin sealants
hemostat
rabbit bleeding models
recombinant fibrinogen/thrombin patch
url http://dx.doi.org/10.1080/08941939.2017.1398789
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