Efficacy, safety, and physicochemical properties of a flowable hemostatic agent made from absorbable gelatin sponge via vacuum pressure steam sterilization.

Abstract

An effective and viable hemostatic agent is important for stopping bleeding during surgery. However, it is difficult to achieve hemostasis at uneven or deep bleeding sites using a gelatin sponge. A flowable hemostatic agent has therefore been developed by processing and improving gelatin sponge, to address bleeding under these conditions. In this study, we evaluated the efficacy, safety, and physical and chemical properties of this flowable hemostatic agent in various experiments. We examined its efficacy for stopping bleeding in a rabbit model of liver abrasion in vivo, and compared its efficacy in dynamic coagulation and erythrocyte aggregation tests with gelatin sponge in vitro. We also investigated its safety in rat histocompatibility and acute systemic toxicity tests in mice in vivo, and in hemolysis tests in vitro, to determine if the flowable hemostatic agent induced any pathological reactions or adverse events. In terms of its physical and chemical properties, we analyzed the morphology and chemical bonds of the flowable hemostatic agent by optical and electron microscopy and infrared spectroscopy, and its absorbency and density. The flowable hemostatic agent resulted in a shorter mean bleeding time, less bleeding, greater likelihood of successful hemostasis, and reduced clotting time compared with gelatin sponge. The flowable agent produced some changes in physical morphology, but no pathological changes or undesirable outcomes were detected. This flowable topical hemostatic agent thus provides a safe and more effective hemostatic method than gelatin sponge, and more promising results for intraoperative hemostasis, especially on uneven or deep bleeding surfaces.