ISO 10993 biological evaluation of novel hemostatic powder ? 4SEAL®

Lukasz Szymanski; Kamila Golaszewska; Anna Wiatrowska; Monika Dropik; Pawel Szymanski; Bartosz Gromadka; Patrycja Krakowiak; Justyna Wierzchowska; Damian Matak

doi:https://doi.org/10.1186/s40824-022-00258-6

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자료유형: 학술저널

저자정보: Lukasz Szymanski (Polish Academy of Science Magdalenka Poland.) Kamila Golaszewska (European Biomedical Institute Poland) Anna Wiatrowska (European Biomedical Institute Poland) Monika Dropik (European Biomedical Institute Poland) Pawel Szymanski (European Biomedical Institute Poland) Bartosz Gromadka (European Biomedical Institute Poland) Patrycja Krakowiak (European Biomedical Institute Poland) Justyna Wierzchowska (European Biomedical Institute Poland) Damian Matak (European Biomedical Institute Poland)

저널정보: 한국생체재료학회 생체재료학회지 생체재료학회지 제26권 제2호

발행연도: 2022.6

수록면: 217 - 236 (20page)

DOI: https://doi.org/10.1186/s40824-022-00258-6

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Background: Hemostasis plays a crucial role during every surgery allowing for a bloodless operating field. Fast and effective surgery leads to a reduced risk of postoperative complications. One of the latest methods for achieving homeostasis is using natural polysaccharide-based hemostatic powders. The study aimed to evaluate the biocompatibility according to the ISO 10993 standards of 4SEAL® Hemostatic powder. Methods: Chemical characterization (Headspace GC-MS, GC-MS, and ICP-MS), cytotoxicity, genotoxicity (MLA and AMES), endotoxin contamination, sensitization potential, intracutaneous reactivity, acute and subacute systemic toxicity with implantation, and pyrogenicity were evaluated to investigate the biocompatibility of the 4SEAL® Hemostatic powder. Studies were conducted according to ISO 10993 standards. Results: The biocompatibility requirements according to ISO 10993-1 for 4SEAL® Hemostatic powder were met. Based on the conducted in-vitro studies, 4SEAL® Hemostatic powder shows a non-cytotoxicity and non-mutagenic potential. Also, the results of in vivo studies of 4SEAL® Hemostatic powder shows no signs of toxicity, non sensitizing, non-irritating, and no pyrogenicity potential. In the chemical characterization of 4Seal® Hemostatic Powder, no compounds were identified above Analytical Evaluation Threshold (AET) and no elements with concentrations higher than element-specific PDE [μg/day] were detected. Conclusions: 4SEAL® Hemostatic powder is a promising new hemostatic agent with a wide range of potential applications and excellent biocompatibility.

#4SEAL hemostatic powder #Biocompatibility #Biological evaluation #ISO 10993 #Hemostatic #Adhesion prevention #Polysaccharide

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Lukasz Szymanski

소속기관 Polish Academy of Science Magdalenka Poland.

주요연구분야 공학 > 기타공학 > 의공학

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Kamila Golaszewska