Ann Surg Treat Res.  2022 Feb;102(2):65-72. 10.4174/astr.2022.102.2.65.

In vivo study for the hemostatic efficacy and foreign body reaction of a new powder-type polysaccharide hemostatic agent

• Byun Y
• Kim EJ
• Lee A
• Suh YA
• Sohn HJ
• Lee JM
• Kang JS
• Choi YJ
• Han Y
• Kim H
• Kwon W
• Jang JY

• KMID: 2525443
• DOI: http://doi.org/10.4174/astr.2022.102.2.65

Abstract

Purpose
Various hemostatic agents have been introduced in therapy as postoperative bleeding is a poor prognostic factor for postoperative outcomes. These products can be divided into those that directly promote the hemostatic cascade and those that physically form a barrier by absorbing blood. The latter, powder-type hemostatic agents have the advantages of being inexpensive and more absorbable with less foreign body reactions (FBRs) and are applicable to a relatively wide area. This study was conducted to verify the safety and efficacy of a newly invented polysaccharide product (OOZFIX, Theracion Biomedical), which improves blood absorption and hemostatic effects.
Methods
Two separate animal experiments were performed. The first evaluated FBRs histologically at 3 days, 2 weeks, and 4 weeks, after implantation of OOZFIX in rats, and the second compared hemostatic performance of OOZFIX and Arista AH (Bard) in the porcine liver punch biopsy model.
Results
We found minimal FBRs in the 3-day group and no reactions in both the 2-week and 4-week groups after implantation of hemostatic agents. The time to hemostasis of OOZFIX was not significantly different from that of Arista AH (median [interquartile range]: 9 [6–10] minutes vs. 8 [6–10] minutes, respectively; P = 0.522). When comparing the serial bleeding grade tendency, there was no statistical difference between OOZFIX and Arista AH (P = 0.656).
Conclusion
OOZFIX caused a minimal FBR that disappeared within 2 weeks in vivo, and its hemostatic performance was comparable with that of an existing agent, Arista AH. Further clinical studies are required in the future.

Keyword

Animal experiment; Foreign body reaction; Hemostatics; Polysaccharides; Porcine liver punch biopsy model

Figure

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  Fig. 1 Representative histopathological pictures for each group (H&E, ×400). (A) 3D group (autopsy 3 days after invagination). (B) 2W group (autopsy 2 weeks after invagination). (C) 4W group (autopsy 4 weeks after invagination).

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  Fig. 2 Representative sequential pictures in the porcine punch biopsy model by OOZFIX (Theracion Biomedical, Seongnam, Korea), Arista AH (Bard, Murray Hill, NJ, USA), and control.

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  Fig. 3 Box-plot showing the time taken to hemostasis for each group. OOZFIX: Theracion Biomedical, Seongnam, Korea; Arista AH: Bard, Murray Hill, NJ, USA. *P < 0.05.

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  Fig. 4 Serial trends of bleeding grade for each group. OOZFIX: Theracion Biomedical, Seongnam, Korea; Arista AH: Bard, Murray Hill, NJ, USA. *P < 0.05.

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