Trials / Withdrawn
WithdrawnNCT06158724
COVID-19 Personal Protective Equipment for Vaccinated Health Workers and Convalescents
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- University Medical Centre Ljubljana · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The aim of the trial is to assess the safety of using simplified personal protective equipment (PPE) for vaccinated or COVID-19 convalescent healthcare workers working in COVID-19 ICU or COVID-19 wards. The trial is designed as a prospective randomized observational trial with volunteer medical staff working in COVID-19 departments aiming to show non-inferiority of simplified PPE vs standard COVID-19 PPE.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Personal Protective Equipment | Simplified PPE for use in COVID-19 departments. |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2021-04-01
- Completion
- 2021-05-01
- First posted
- 2023-12-06
- Last updated
- 2024-12-20
Locations
1 site across 1 country: Slovenia
Source: ClinicalTrials.gov record NCT06158724. Inclusion in this directory is not an endorsement.