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

Study Overview
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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.

Official Title
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Self-contamination Following Removal of Two Personal Protective Equipment Suits: a Randomized, Controlled, Crossover Simulation Trial

Conditions
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Personal Protective Equipment, Self Contamination

Intervention / Treatment
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* Other: Gown personal protective equipment (PPE-G) suit
* Other: Coverall personal protective equipment (PPE-C) suit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anesthesiology Department member (Hospital Italiano de Buenos Aires, Buenos Aires, Argentina), participation in the PPE training workshop. Exclusion Criteria: Refusal to participate in the study Known allergy to any of the components of the fluorescent lotion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PPE-G (gown) followed by PPE-C (coverall)<br>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) suit<br>* 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.<br>Other: Coverall personal protective equipment (PPE-C) suit<br>* 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.<br>|
| Active Comparator: PPE-C (coverall) followed by PPE-G (gown)<br>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) suit<br>* 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.<br>Other: Coverall personal protective equipment (PPE-C) suit<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between self-contamination and adherence to the PPE removal protocol | Graphical illustration of adherence in the X axis and number of traces in the Y axis and calculation of the Spearman's rank-order correlation coefficient. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sars-cov-2, personal protective equipment, self-contamination, fluorescent solution, healthcare simulation