Department of Orthopaedic and Trauma Surgery, "Magna Græcia" University, "Mater Domini" University Hospital, V.Le Europa, (Loc. Germaneto), 88100, Catanzaro, Italy.
Int Orthop. 2022 Jun;46(6):1233-1240. doi: 10.1007/s00264-022-05371-8. Epub 2022 Mar 16.
The rapid spread of coronavirus disease 2019 (COVID-19) has increased the use of personal protective equipment. The purpose of this study was to investigate whether a commercially available sterile surgical helmet system (SSHS) can be considered protective against COVID-19 and therefore safe for use.
A double-blinded randomized controlled study was performed to investigate the efficacy of the ViVi® SSHS with a high-efficiency particulate air filter called HFD Hood (THI, Total Healthcare Innovation GmbH, Feistritz im Rosental, Austria) to protect against respiratory droplets. Forty recruited participants were divided into two different groups. The SSHS was tested using a validated qualitative test for respirator masks through saccharin or placebo solutions based on random allocation into two cohorts. Saccharin droplets are a validated surrogated marker for any elements of viral size, such as coronaviruses. A positive report of sweet taste after saccharin exposure was suggestive of ViVi® SSHS inefficacy in protection against droplets.
One participant out of 21 (4.8%) reported positive for taste within the placebo cohort, while five out of 19 (26.3%) reported positive for taste within the saccharin cohort upon testing. Two out of 21 (9.5%) participants reported positive for taste within the placebo cohort, and two out of 19 (10.5%) reported positive for taste within the saccharin cohort upon retesting. There were no statistically significant differences between the saccharin and placebo groups in either the test or retest measurements (p = 0.085 and p = 1.000, respectively).
This study demonstrates that the ViVi® SSHS equipped with HFD Hood protects against respiratory droplets, increasing protection against several microorganisms, including the virus that causes COVID-19, allowing surgeons to carry out procedures on COVID-positive patients in a more comfortable and safer way.
2019 年冠状病毒病（COVID-19）的迅速传播增加了个人防护设备的使用。本研究旨在调查市售的无菌手术头盔系统（SSHS）是否可被视为对 COVID-19 具有防护作用，因此安全可用。
进行了一项双盲随机对照研究，以调查配备高效空气颗粒过滤器（HFD Hood）的 ViVi® SSHS 防止飞沫的功效。招募了 40 名参与者，并将他们分为两组。通过基于随机分配的蔗糖或安慰剂溶液对 SSHS 进行了经过验证的呼吸面罩定性测试。蔗糖液滴是大小与任何病毒元素（例如冠状病毒）相当的验证替代标志物。暴露于蔗糖后报告甜味阳性提示 ViVi® SSHS 无法有效防止飞沫。
在安慰剂组中，有 1 名参与者（4.8%）报告味觉阳性，而在蔗糖组中，有 5 名参与者（26.3%）报告味觉阳性。在安慰剂组中，有 2 名参与者（9.5%）报告味觉阳性，在蔗糖组中，有 2 名参与者（10.5%）报告味觉阳性。在测试和复测中，蔗糖组和安慰剂组之间在任何测量值上均无统计学差异（分别为 p=0.085 和 p=1.000）。
本研究表明，配备 HFD Hood 的 ViVi® SSHS 可防止飞沫，增加对包括引起 COVID-19 的病毒在内的多种微生物的保护，使外科医生能够以更舒适、更安全的方式对 COVID-19 阳性患者进行手术。
