Clinical Research Laboratory, Department of Thoracic, Cardiac and Vascular Surgery, University Hospital Tuebingen, Tuebingen University, Tuebingen, 72076, Germany.
Clinical Regulatory Affairs, Lohmann & Rauscher GmbH &Co KG, Neuwied, Germany.
J Biomed Mater Res B Appl Biomater. 2019 Aug;107(6):1877-1888. doi: 10.1002/jbm.b.34280. Epub 2018 Nov 22.
Cotton-based surgical invasive devices with their desired hemostyptic properties have been used for decades in the surgical field. However, in cardiac surgery using the heart-lung machine with direct retransfusion of suction blood, activated blood may re-enter the circulation without filtration and may trigger a cascade reaction leading to systemic inflammation and thrombosis. We therefore set out to evaluate the inflammatory potential of untreated and pyrogen-impregnated cotton-based surgical invasive medical devices. After incubation of the swabs with whole blood or PBMC, the cell-free supernatant was investigated for IL1β and IL6. While the reaction of human whole blood toward cotton swabs could not be influenced by any sterilization technique, dry heat and gamma-irradiation were able to diminish the inflammatory reaction of PBMC toward the material and the used pyrogens. In conclusion, using PBMC in direct contact to cotton we are the first to establish a suitable test method for quantification of the pyrogenic/inflammatory activity of this material. The unaltered reaction of whole blood, however, suggests a crosstalk of cells and plasma proteins in the inflammation activation that is not prevented by sterilization of the swabs. This new in vitro testing methodology may help to better display the clinical situation during development of new materials. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 1877-1888, 2019.
以棉花为基础的外科侵入性医疗器械具有理想的止血性能,几十年来一直在外科领域中使用。然而,在使用心肺机直接回输吸引血的心脏手术中,激活的血液可能未经过滤重新进入循环,并可能引发级联反应,导致全身炎症和血栓形成。因此,我们着手评估未经处理和热原浸渍的以棉花为基础的外科侵入性医疗器械的炎症潜力。将拭子与全血或 PBMC 孵育后,研究无细胞上清液中 IL1β 和 IL6 的情况。虽然任何灭菌技术都不能影响人体全血对棉花拭子的反应,但干热和γ辐射能够降低 PBMC 对材料和使用的热原的炎症反应。总之,使用直接接触棉花的 PBMC,我们首次建立了一种合适的测试方法,用于定量这种材料的热原/炎症活性。然而,全血未改变的反应表明,在炎症激活过程中细胞和血浆蛋白之间存在交联,而拭子的灭菌并不能防止这种交联。这种新的体外测试方法可能有助于在新材料的开发过程中更好地显示临床情况。©2018 威利父子公司。J 生物医学材料研究部分 B:应用生物材料 107B:1877-1888,2019.