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

Shinsuke Katsuyama, Yasuhiro Miyazaki, Satoru Kobayashi, Yoshie Nakagawa, Keiichi Yamamoto, Koji Tanaka, Tomoki Makino, Tsuyoshi Takahashi, Yukinori Kurokawa, Makoto Yamasaki, Masaki Mori, Yuichiro Doki, Kiyokazu Nakajima

Research output: Contribution to journalArticle

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.

Original languageEnglish
JournalMinimally Invasive Therapy and Allied Technologies
DOIs
Publication statusPublished - Jan 1 2019

All Science Journal Classification (ASJC) codes

  • Surgery

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    Katsuyama, S., Miyazaki, Y., Kobayashi, S., Nakagawa, Y., Yamamoto, K., Tanaka, K., Makino, T., Takahashi, T., Kurokawa, Y., Yamasaki, M., Mori, M., Doki, Y., & Nakajima, K. (2019). Novel, infection-free, advanced hemostatic material: physical properties and preclinical efficacy. Minimally Invasive Therapy and Allied Technologies. https://doi.org/10.1080/13645706.2019.1627373