Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT06831305
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-26
First Post:
2025-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bacterial Colonization on Nails Covered With a Methacrylic Coating
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': ['CARE_PROVIDER']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of microbial colonization between natural and methacrylate nails', 'timeFrame': 'From day 1st to the end of treatment on day 14th'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['methacrylates', 'nails', 'desinfection', 'transmission of infections'], 'conditions': ['Bacterial Colonization']}, 'descriptionModule': {'briefSummary': 'In the research, the investigators will monitor the bacterial colonization of nails coated with a methacrylic coating', 'detailedDescription': 'It is known that the hand hygiene of healthcare workers is extremely important in order to prevent health-related infections. The effectiveness of hand disinfection can be affected by aspects of hand hygiene such as long nails and fingernail applications. In order to determine whether and to what extent fingernails applied among healthcare workers pose a risk of transmission of potentially pathogenic bacteria, and until what day artificial fingernails are safe in healthcare workers, the investigators will monitor bacterial colonization on nails with UV-cured methacrylic fingernails lamp and compared it with a control group of natural nails without application.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nurses, doctors and respiratory physiotherapists employed in high-risk wards for patients\n* healthy nail surface and cuticle\n\nExclusion Criteria:\n\n* subjects with damaged nails or cuticles\n* operating room staff using surgical hand brushing and staff in general nursing wards.'}, 'identificationModule': {'nctId': 'NCT06831305', 'briefTitle': 'Bacterial Colonization on Nails Covered With a Methacrylic Coating', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Bacterial Colonization of Nails With Methacrylic Coating in Relation to the Formation of Biofilms and Healthcare-associated Infections', 'orgStudyIdInfo': {'id': '0120-301/2024-2711-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'natural nails', 'description': 'Alcohol hand sanitizer 3ml applied into hands, spread over hands up to the wrist and rubbed until dry on natural nails.', 'interventionNames': ['Diagnostic Test: Comparison of microbiological sampling on natural nails']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'methaacrylic nails', 'description': 'Alcohol hand sanitizer 3ml applied into hands, spread over hands up to the wrist and rubbed until dry on methaacrylic nails', 'interventionNames': ['Diagnostic Test: Comparison of microbiological sampling on methacrylic nails']}], 'interventions': [{'name': 'Comparison of microbiological sampling on natural nails', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['natural nails'], 'description': 'Comparison of microbiological sampling before and after hand desinfection', 'armGroupLabels': ['natural nails']}, {'name': 'Comparison of microbiological sampling on methacrylic nails', 'type': 'DIAGNOSTIC_TEST', 'description': 'Comparison of microbiological sampling on methacrylic nails', 'armGroupLabels': ['methaacrylic nails']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Center Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}