Efficacy of a Novel Hemostatic Material “Sodium Calcium Alginate’’ in a Porcine Acute Phase Model

Abstract

Introduction

Although biologically derived hemostatic materials have satisfactory performance, they involve the risk of infection. We have developed a novel hemostatic material, sodium calcium alginate (Na/Ca alginate), based on the nonbiological material sodium alginate. This study aimed to evaluate the hemostatic efficacy of our Na/Ca alginate compared with conventional nonbiological and biological agents.

Methods

We manufactured the Na/Ca alginate with optimized hemostatic properties according to our previous studies. We adopted microporous starch and oxidized cellulose as nonbiological existing hemostatic agents and fibrin glue as an existing biological hemostatic agent. Standardized punch-out wounds were created in porcine livers using a biopsy punch. Each hemostatic material was then applied, and hemostatic efficacy was evaluated at 2 and 5 min after application.

Results

The degree of bleeding was comparable at each group. Na/Ca alginate showed significantly higher hemostatic efficacy than microporous starch and oxidized cellulose at 2 min after application (Na/Ca alginate 90% versus microporous starch 0% versus oxidized cellulose 50%, P < 0.01). The finding persisted at 5 min (86.7% versus 0% versus 43.3%, P < 0.01). Na/Ca alginate also showed significantly higher hemostatic efficacy compared to fibrin glue at 2 min (Na/Ca alginate 94.1% versus fibrin glue 50.0%, P < 0.01). At the 5-min evaluation, there was no statistically significant difference between Na/Ca alginate and fibrin glue (94.1% versus 85.3%, P = 0.427).

Conclusions

Our novel Na/Ca alginate demonstrated superior hemostatic efficacy compared to existing nonbiological hemostatic agents and achieved more rapid hemostasis than the existing biological hemostatic agent.