Purpose
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.
Methods
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.
Results
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).
Conclusions
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.
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