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

Not Applicable

Completed

• Conditions: Personal Protective Equipment; Self Contamination
• Interventions: Other: Gown personal protective equipment (PPE-G) suit; Other: Coverall personal protective equipment (PPE-C) suit

• Registration Number: NCT04763304
• Lead Sponsor: Hospital Italiano de Buenos Aires

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2020-10-29
• Study Completion: 2020-11-18
• Status Verified: 2021-02
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-18
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PPE-G (gown) followed by PPE-C (coverall)	Coverall personal protective equipment (PPE-C) suit	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.
PPE-C (coverall) followed by PPE-G (gown)	Gown personal protective equipment (PPE-G) suit	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.
PPE-G (gown) followed by PPE-C (coverall)	Gown personal protective equipment (PPE-G) suit	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.
PPE-C (coverall) followed by PPE-G (gown)	Coverall personal protective equipment (PPE-C) suit	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.

Primary Outcome Measures

Name	Time	Method
Mean within-participant difference in self-contamination between PPE-G and PPE-C suits	20 minutes	Mean difference between paired observations (number of fluorescent traces, any size, any body zone, per PPE suit) from each participant.

Secondary Outcome Measures

Name	Time	Method
Correlation between self-contamination and adherence to the PPE removal protocol	5 minutes	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.

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina