The aim of the trial is to assess the safety of using simplified personal protectiveequipment (PPE) for vaccinated or COVID-19 convalescent healthcare workers working inCOVID-19 ICU or COVID-19 wards.The trial is designed as a prospective randomized observational trial with volunteermedical staff working in COVID-19 departments aiming to show non-inferiority ofsimplified PPE vs standard COVID-19 PPE.
Objectives To assess safety of simplified personal protective equipment (PPE) for
vaccinated health workers and COVID-19 convalescents - pilot trial.
Methods Prospective randomized observational trial. 60 participants randomized 1:1 to
either standard PPE (COVID-19 ward: FFP2 or higher respirator, goggles of face shield,
gown, gloves; COVID-19 ICU: FFP3 respirator and tight goggles or full face mask or
powered air-purifying respirators, gown and gloves) or simplified PPE (surgical mask,
goggles or face shield, gown). 30 days follow up period.
Participants Volunteer medical staff from COVID-19 regular and ICU departments at
University Medical Center Ljubljana, Slovenia, with either proven COVID-19 infection
within 6 months or at least 7 days after second dose anti COIVD-19 vaccine.
Hypotheses Simplified PPE is non-inferior to standard PPE in vaccinated health workers or
convalescents.
Discussion Positive study results may decrease PPE spending cost and positively affect
working conditions at COVID-19 departments.
Other: Personal Protective Equipment
Simplified PPE for use in COVID-19 departments.
Inclusion Criteria:
- age < 50 years
- prior COVID-19 infection; time from infection < 6 months.
- prior completed anti COVID-19 immunization; > 1 week post second dose of
immunization.
- signed written consent
- negative nasopharyngeal COVID-19 RT-PCR test
Exclusion Criteria:
- age > 50 years
- time post COVID-19 infection > 6 months
- time post COVID-19 immunization < 1 week.
- immunocompromised patients
- pregnancy
- CKD 3 or more
- COPD or other lung disease
- heart failure of any cause
- ischemic heart disease
- obesity (BMI > 30)
- DM on therapy
University Medical Center Ljubljana
Ljubljana 3196359, Slovenia
Not Provided