Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT04763304
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2021-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self-contamination Following Removal of Two Personal Protective Equipment Suits: a Crossover Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "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."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-02-18', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean within-participant difference in self-contamination between PPE-G and PPE-C suits', 'timeFrame': '20 minutes', 'description': 'Mean difference between paired observations (number of fluorescent traces, any size, any body zone, per PPE suit) from each participant.'}], 'secondaryOutcomes': [{'measure': 'Correlation between self-contamination and adherence to the PPE removal protocol', 'timeFrame': '5 minutes', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sars-cov-2', 'personal protective equipment', 'self-contamination', 'fluorescent solution', 'healthcare simulation'], 'conditions': ['Personal Protective Equipment', 'Self Contamination']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anesthesiology Department member (Hospital Italiano de Buenos Aires, Buenos Aires, Argentina), participation in the PPE training workshop.\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Known allergy to any of the components of the fluorescent lotion'}, 'identificationModule': {'nctId': 'NCT04763304', 'briefTitle': 'Self-contamination Following Removal of Two Personal Protective Equipment Suits: a Crossover Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Self-contamination Following Removal of Two Personal Protective Equipment Suits: a Randomized, Controlled, Crossover Simulation Trial', 'orgStudyIdInfo': {'id': '5646'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PPE-G (gown) followed by PPE-C (coverall)', 'description': '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.\n\nPlacement 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.', 'interventionNames': ['Other: Gown personal protective equipment (PPE-G) suit', 'Other: Coverall personal protective equipment (PPE-C) suit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PPE-C (coverall) followed by PPE-G (gown)', 'description': '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.\n\nPlacement 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.', 'interventionNames': ['Other: Gown personal protective equipment (PPE-G) suit', 'Other: Coverall personal protective equipment (PPE-C) suit']}], 'interventions': [{'name': 'Gown personal protective equipment (PPE-G) suit', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['PPE-C (coverall) followed by PPE-G (gown)', 'PPE-G (gown) followed by PPE-C (coverall)']}, {'name': 'Coverall personal protective equipment (PPE-C) suit', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['PPE-C (coverall) followed by PPE-G (gown)', 'PPE-G (gown) followed by PPE-C (coverall)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1199', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'At time of publication.', 'ipdSharing': 'YES', 'description': 'All collected IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'DELFINA SANCHEZ NOVAS', 'investigatorAffiliation': 'Hospital Italiano de Buenos Aires'}}}}