Self-contamination Following Removal of Two Personal Protective Equipment Suits: a Crossover Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2020-11-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Personal Protective Equipment Self Contamination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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

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.

Group Type ACTIVE_COMPARATOR

Gown personal protective equipment (PPE-G) suit

Intervention Type OTHER

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.

Coverall personal protective equipment (PPE-C) suit

Intervention Type OTHER

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)

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.

Group Type ACTIVE_COMPARATOR

Gown personal protective equipment (PPE-G) suit

Intervention Type OTHER

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.

Coverall personal protective equipment (PPE-C) suit

Intervention Type OTHER

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.

Interventions

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Gown personal protective equipment (PPE-G) suit

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.

Intervention Type OTHER

Coverall personal protective equipment (PPE-C) suit

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.

Intervention Type OTHER