NCT04712045

Brief Summary

This study aims to improve the personal protective equipment (PPE) used while treating patients with COVID-19, to protect staff and avoid cross-infection of patients. Protecting staff from infection during the Covid pandemic is critical to maintaining health services. Mistakes in using protective equipment (PPE) are the commonest avoidable factor in staff becoming infected at work. Recently, intensive care doctors have also reported an increase in the spread of dangerous multi-resistant bacteria between patients, which appears likely to be transmitted between patients by Level 2 PPE worn by staff (specifically gown sleeves). This study therefore seeks to develop and test a new protocol to decrease cross-infection risks whilst using Level 2 PPE.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

January 11, 2021

Last Update Submit

January 13, 2021

Conditions

Covid19Personal Protective Equipment

Keywords

PPEMulti-drug resistance organismCross-infection

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants and simulated patients with contamination as assessed by ultraviolet light

    The primary outcome of this study is the proportion of participants and simulated patients who were contaminated with fluorescent powder as examined under a UV light, using a response of "YES" or "NO", when participants wore new (experimental) Level 2 PPE in comparison to the standard (control) Level 2 PPE

    immediately after simulations

Secondary Outcomes (3)

  • Participants' perception of personal comfort and safety and safety of the patients as assessed through structured questionnaire

    immediately before simulations and immediately after simulations

  • changes in participants perception of personal comfort and safety and safety of patients as assessed through a semi-structured questionnaire

    immediately before training, immediately after training and immediately after simulation

  • The difference in the area of contamination between New and Standard PPE as analyzed through python script

    immediately after simulations

Study Arms (2)

New PPE

EXPERIMENTAL

Use of Short sleeve gown and single pair of gloves

Other: New PPE

Old PPE

ACTIVE COMPARATOR

Use of Long sleeve gown and double pairs of gloves

Other: Old PPE

Interventions

New PPEOTHER

The use of a new protocol of level 2 PPE which involves wearing a short-sleeve gown and a single pair of gloves

New PPE
Old PPEOTHER

The use of a standard protocol of level 2 PPE which involves wearing a long-sleeve gown and double pairs of gloves

Old PPE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • NHS staff and works in the Adult Intensive Care Unit, Neuro Intensive Care Unit or Cardio-thoracic Intensive Care Unit
  • Trained in the correct use of Level 2 PPE according to current guidance
  • Trained in ICU COVID19 Intubation and Proning protocols
  • Willing and able to give informed consent for participation in the study.

You may not qualify if:

  • \. taking any medication which can cause photosensitivity reactions in the preceding 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professor Peter McCulloch

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

COVID-19Cross Infection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter McCulloch

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgical Science and Practice

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 15, 2021

Study Start

August 1, 2020

Primary Completion

December 12, 2020

Study Completion

December 12, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)