Personal Protective EquipmentNCT04763304
Self-contamination Following Removal of Two Personal Protective Equipment Suits: a Crossover Trial
A study testing Gown personal protective equipment (PPE-G) suit and Coverall personal protective equipment (PPE-C) suit in people with Personal Protective Equipment and Self Contamination, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Personal Protective Equipment, Self Contamination
- What is being tested?
- Gown personal protective equipment (PPE-G) suit and Coverall personal protective equipment (PPE-C) suit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Sep 2020to 18 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anesthesiology Department member (Hospital Italiano de Buenos Aires, Buenos Aires, Argentina), participation in the PPE training workshop.
Who cannot join
- Refusal to participate in the study
- Known allergy to any of the components of the fluorescent lotion
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1199
About this study
Official title: Self-contamination Following Removal of Two Personal Protective Equipment Suits: a Randomized, Controlled, Crossover Simulation Trial
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.
- Conditions
- Personal Protective Equipment, Self Contamination
- Being tested
- Gown personal protective equipment (PPE-G) suit, Coverall personal protective equipment (PPE-C) suit
- Keywords
- sars-cov-2, personal protective equipment, self-contamination, fluorescent solution, healthcare simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Gown personal protective equipment (PPE-G) suit; Other: 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. Receives: Other: Gown personal protective equipment (PPE-G) suit; Other: Coverall personal protective equipment (PPE-C) suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (1)
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Sep 2020
- Primary completion29 Oct 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personal Protective EquipmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DELFINA SANCHEZ NOVAS, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763304
- Sponsor's protocol ID
- 5646
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-contamination Following Removal of Two Personal Protective Equipment Suits: a Randomized, Controlled, Crossover Simulation Trial
- ClinicalTrials.gov ID
- NCT04763304
- Acronym / sponsor ID
- 5646
- Conditions
- Personal Protective Equipment, Self Contamination
- Keywords
- sars-cov-2, personal protective equipment, self-contamination, fluorescent solution, healthcare simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PPE-G (gown) followed by PPE-C (coverall) | Active comparator | Other: Gown personal protective equipment (PPE-G) suit, Other: Coverall personal protective equipment (PPE-C) suitPlacement 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) | Active comparator | Other: Gown personal protective equipment (PPE-G) suit, Other: Coverall personal protective equipment (PPE-C) suitPlacement 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesiology Department member (Hospital Italiano de Buenos Aires, Buenos Aires, Argentina), participation in the PPE training workshop.
Key exclusion criteria (2 listed)
- Refusal to participate in the study
- Known allergy to any of the components of the fluorescent lotion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gown personal protective equipment (PPE-G) suitPlacement 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. | Other | PPE-C (coverall) followed by PPE-G (gown), PPE-G (gown) followed by PPE-C (coverall) |
| Coverall personal protective equipment (PPE-C) suitPlacement 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. | Other | PPE-C (coverall) followed by PPE-G (gown), PPE-G (gown) followed by PPE-C (coverall) |
Primary outcome
Mean within-participant difference in self-contamination between PPE-G and PPE-C suits
Time frame: 20 minutes
Mean difference between paired observations (number of fluorescent traces, any size, any body zone, per PPE suit) from each participant.
1 secondary outcome
Correlation between self-contamination and adherence to the PPE removal protocol
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: Yes. All collected IPD
Related trials for Personal Protective Equipment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gown personal protective equipment (PPE-G) suit and Coverall personal protective equipment (PPE-C) suit in people with Personal Protective Equipment and Self Contamination, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean within-participant difference in self-contamination between PPE-G and PPE-C suits (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.