Hemostatic efficacy evaluation and safety profile of a cellulose nanofiber mat

Abstract

Although the hemostatically efficacious nature of cellulose nanofibers (CNFs) is well established, data regarding their hemostatic performance in large animal systems and safety toward human skin cells, which are critical factors for clinical translation, are lacking. This study evaluated the clinical potential of CNF-coated gauze by testing its hemostatic efficacy in rats, rabbits, and pigs, and assessing its safety in human primary cells through differential gene expression (DEG) analysis. In-vitro studies using rabbit blood revealed that the CNF-coated gauze exhibited a significantly lower blood clotting index (BCI) value than gauze coated with chitosan, a commonly used hemostatic agent, indicating superior blood clotting. In-vivo tests on bleeding-induced pig livers revealed that the CNF-coated gauze delivered a four-fold higher hemostatic success rate reduced bleeding volume compared to regular gauze. Moreover, a rat wound-healing model revealed improved healing with CNF-coated gauze. DEG analysis of human dermal fibroblast primary cells showed no statistically significant differences between the CNF and control groups, indicating its human safety. Overall, our results suggest that CNF-coated hemostatic gauze absorbs blood rapidly, delivers superior hemostatic performance compared to regular gauze, is safe from both histological and DEG perspectives, and is therefore suitable for use in healthcare and clinical settings.