Novel, infection-free, advanced hemostatic material: physical properties and preclinical efficacy

Abstract

Introduction: Self-assembling peptides are synthetic, amphipathic peptides that may serve as new hemostatic agents. The first-generation hemostat TDM-621 has been used in clinical practice in a limited capacity. The second-generation hemostat TDM-623 was developed for faster gel formation and better tissue-sealing capability. We compared the physical properties and hemostatic effects of TDM-621 and TDM-623.Material and methods: First, we evaluated the physical properties of both materials in a bench test setting, including the external appearance of the gel, rheological properties in sol/gel forms, and local self-weight pressure. We then performed a randomized preclinical trial using swine. Bleeding wounds were created on the liver surface, and randomized application of 1 mL of either TDM-621 or TDM-623 was performed. The hemostatic effects were evaluated two and five minutes after application. Resected specimens were histologically evaluated.Results: In the bench test setting, TDM-623 showed higher gel height, higher sol viscosity, and higher local self-weight pressure than TDM-621. In the preclinical setting, TDM-623 showed significantly greater hemostatic effects at two and five minutes after application than TDM-621. Histological examination showed no inflammatory reaction in either group.Conclusions: TDM-623 has greater hemostatic capability than TDM-621 and is therefore promising as a new hemostatic agent.