Medical Devices: Evidence and Research (Jun 2023)
Safety and Performance of Hemostatic Powders
Abstract
Lukasz Szymanski,1,2 Kamila Gołaszewska,2 Justyna Małkowska,2 Judyta Kaczyńska,2 Małgorzata Gołębiewska,2 Bartosz Gromadka,2 Damian Matak2 1Department of Molecular Biology, Institute of Genetics and Animal Biotechnology, Polish Academy of Science, Magdalenka, 05-552, Poland; 2European Biomedical Institute, Jozefow, 05-410, PolandCorrespondence: Damian Matak, Email [email protected]: Hemorrhage, a sudden and severe leakage of blood due to the disruption of blood vessels, is one of the most common causes of death from injuries worldwide. Severe bleeding accounts for more than 35% of pre-hospital deaths and about 40% of deaths recorded within 24 hours of injury. One of the methods for achieving homeostasis is the use of hemostatic powders. This study compares the basic safety and performance of the most popular hemostatic powders.Methods: Basic safety of commercially available products were evaluated using MTT, MEM elution assay, and endotoxin testing. The in vitro performance was evaluated using water absorption capacity, water absorption rate, and adhesion strength assays.Results: 4Seal, Starsil, and 4DryField extracts did not cause cytotoxicity in MTT and MEM elution assays. PerClot and SuperClot extracts demonstrated cytotoxic potential in MTT assay, while Arista extract was cytotoxic in both MEM elution and MTT assays. 4Seal has the lowest endotoxin contamination, followed by PerClot, 4DryField, SuperClot, Arista, and Starsil. 4Seal and Starsil showed significantly highest WAR among the tested samples, followed by 4DryField, Arista, PerClot, and SuperClot. Adhesion force is highest for 4Seal, followed by Starsil, PerClot, 4DryField Arista, and SuperClot.Conclusion: 4Seal is the most versatile in terms of safety and functional properties compared to 4DryField, Arista, PerClot, Starsil, and SuperClot.Keywords: hemostasis, hemostatic powder, bleeding, 4DryField, 4Seal, Arista, PerClot, Starsil, SuperClot
