NCT04763304

Brief Summary

Anesthesiologists and other professionals are at high risk of viral infection during aerosol-generating procedures. Knowledge of the protective quality of PPE suits and the risk of self-contamination after removal is paramount. This trial used an ultraviolet-fluorescent solution to explore differences in self-contamination after removal of gown PPE (PPE-G) and coverall PPE (PPE-C). A two-period/two-intervention (AB/BA) design was chosen; each intervention consisted of audio-guided placement of PPE, full-body spraying of fluorescent solution, audio-guided removal of PPE, and assessment of self-contamination through ultraviolet light scanning. The primary outcome was the mean within-participant difference (traces of any size) between PPE suits. Statistical significance was tested using t test for paired data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 15, 2021

Last Update Submit

February 18, 2021

Conditions

Personal Protective EquipmentSelf Contamination

Keywords

sars-cov-2personal protective equipmentself-contaminationfluorescent solutionhealthcare simulation

Outcome Measures

Primary Outcomes (1)

  • Mean within-participant difference in self-contamination between PPE-G and PPE-C suits

    Mean difference between paired observations (number of fluorescent traces, any size, any body zone, per PPE suit) from each participant.

    20 minutes

Secondary Outcomes (1)

  • Correlation between self-contamination and adherence to the PPE removal protocol

    5 minutes

Study Arms (2)

PPE-G (gown) followed by PPE-C (coverall)

ACTIVE COMPARATOR

Placement of PPE-G (personal protective equipment including a gown for body protection) fluorescent solution full-body spray, removal of PPE-G and assessment of self-contamination through ultraviolet light scanning. Placement of PPE-C (personal protective equipment including a coverall for body protection), fluorescent solution full-body spray, removal of PPE-C and assessment of self-contamination through ultraviolet light scanning.

Other: Gown personal protective equipment (PPE-G) suitOther: Coverall personal protective equipment (PPE-C) suit

PPE-C (coverall) followed by PPE-G (gown)

ACTIVE COMPARATOR

Placement of PPE-C (personal protective equipment including a coverall for body protection), fluorescent solution full-body spray, removal of PPE-C and assessment of self-contamination through ultraviolet light scanning. Placement of PPE-G (personal protective equipment including a gown for body protection), fluorescent solution full-body spray, removal of PPE-G and assessment of self-contamination through ultraviolet light scanning.

Other: Gown personal protective equipment (PPE-G) suitOther: Coverall personal protective equipment (PPE-C) suit

Interventions

Gown personal protective equipment (PPE-G) suitOTHER

Placement of PPE-G under direct instructions (audio recording), fluorescent solution full-body spray, removal of PPE under direct instructions (audio recording) and assessment of self-contamination through ultraviolet light scanning. Active (wet wipe cleanse of any fluorescent traces visible under ultraviolet light scanning) and passive (15 minute interval) washout period to prevent a carry over effect on the second allocated intervention.

PPE-C (coverall) followed by PPE-G (gown)PPE-G (gown) followed by PPE-C (coverall)
Coverall personal protective equipment (PPE-C) suitOTHER

Placement of PPE-C under direct instructions (audio recording), fluorescent solution full-body spray, removal of PPE under direct instructions (audio recording) and assessment of self-contamination through ultraviolet light scanning. Active (wet wipe cleanse of any fluorescent traces visible under ultraviolet light scanning) and passive (15 minute interval) washout period to prevent a carry over effect on the second allocated intervention.

PPE-C (coverall) followed by PPE-G (gown)PPE-G (gown) followed by PPE-C (coverall)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anesthesiology Department member (Hospital Italiano de Buenos Aires, Buenos Aires, Argentina), participation in the PPE training workshop.

You may not qualify if:

  • Refusal to participate in the study
  • Known allergy to any of the components of the fluorescent lotion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aire, Buenos Aires, 1199, Argentina

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In a specific area, the blinded outcome assessor (researcher #2) performed standardized scanning of participants' skin and base clothing using ultraviolet light in a dark room, revealing the presence of any fluorescent traces. The seven body zones assessed were face, anterior and posterior neck, arms, hands, clothing (anterior/posterior, upper, and lower clothing), and foot covers. Fluorescent traces were measured (small traces, ≤1 cm; large traces, \>1 cm) and quantified for statistical analyses.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: We designed a prospective, randomized, controlled crossover trial with a total of 60 healthy anesthesia personnel volunteers. A two-period/two-intervention (AB/BA) design was chosen for this trial in order to estimate differences between both PPE suits with greater precision, given there is no participant variation between groups. The primary outcome was within-participant variability. A potential carryover effect was not expected considering the combination of an active (wet wipe cleansing) and passive (15 minute interval) washout period between interventions. All participants were randomly allocated to either intervention sequence: PPE-G (personal protective equipment including a gown for body protection) followed by PPE-C (personal protective equipment including a coverall for body protection) or PPE-C followed by PPE-G. Both interventions took place on the same day.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 21, 2021

Study Start

September 1, 2020

Primary Completion

October 29, 2020

Study Completion

November 18, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
At time of publication.

Locations

AR(1)