Evaluation of the Safety and Efficacy of Chitosan-Based Hemostatic Sponges in a Chronic Large-Animal Model

Background: The development of agents aimed at achieving hemostasis in parenchymal organ bleeding remains one of the current challenges in medicine. Chitosan-based sponges are considered a promising approach to achieving effective hemostasis. The safety of these products was previously demonstrated in a 60-day experiment in rats. AIM: To evaluate the efficacy and safety of chitosan-based hemostatic sponge samples in a standardized liver trauma model in pigs during a long-term experiment. MATERIALS AND METHODS: The study was conducted in three same-sex pigs. A standardized model of intraperitoneal bleeding was created using laparoscopic access, followed by the application of a chitosan-based hemostatic sponge, which was left in the abdominal cavity for the entire duration of the experiment. The animals were observed for 60 days, during which general condition, body weight, and complete blood count were monitored. On day 30, repeat laparoscopy was performed to visually inspect the trauma site. At the end of the observation period, the animals were euthanized. RESULTS: The hemostatic sponge provided complete hemostasis of parenchymal bleeding, with no recurrence of bleeding. No behavioral abnormalities were observed in animals throughout the entire experiment. Blood parameters remained within reference ranges. On day 30, repeat laparoscopy revealed adhesion formation and encapsulation of the hemostatic sponge in the peritoneal cavity. Histological examination of liver tissue on day 60 revealed an increased number of inflammatory cells at the site of contact with the hemostatic sponge. Maturation of granulomatous connective tissue in the liver was also observed, suggesting active wound healing. CONCLUSION: The developed chitosan-based hemostatic sponge demonstrated both efficacy and biocompatibility, which allow it to remain in the abdominal cavity throughout medical evacuation. However, subsequent removal is recommended to prevent adhesion formation and potential peritoneal inflammation.