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

Personal Protective Equipment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04763304
• Other study ID #: 5646
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: November 18, 2020

Study information

• Verified date: February 2021
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 18, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Personal Protective Equipment
• Self Contamination

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Ciudad Autonoma de Buenos Aire	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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