COVID-19 – The efficacy of the LEAF-mask measured by assessing the viral load of the mask's inner and outer surface used by nurses in ICUs compared to the N95: a phase II, multicenter, randomized, controlled, open-label, clinical trial protocol

Introduction: The unprecedented, worldwide COVID-19 pandemic demanded the need for adequate personal protective equipment (PPE) health care workers (HCWs). commonly recommended N95-mask (N95) needs further optimization in areas of technology, re-usability, and comfort. LEAF-mask (LEAF) reportedly offers improved technology innovative features, however, neither them have been tested yet. Therefore, there is an ongoing to study efficacy masks used by HCWs intensive units (ICUs). goal this demonstrate superiority LEAF nurses working ICUs when compared N95.Methods: A phase-II, multicenter, randomized, controlled, open-label, clinical trial. sample size 98 nurses, ICUs, will be necessary detect a significant difference viral load inner outer parts both as primary outcome. Secondary outcomes exploratory nature, including adverse effects, wearing comfort masks, virus infection rate.Discussion: has already infected killed millions people burdens healthcare systems worldwide. This led search comprehensive measures prevent spread SARS-CoV-2, particular among frontline. intends new N95, primarily but also re-usability ICUs. possible findings from on technologies features possibly shown may greatly contribute better conditions