Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-31 @ 11:50 PM
Study NCT ID:
NCT04935892
Status:
COMPLETED
Last Update Posted:
2021-06-25
First Post:
2021-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Slippers to Reduce Transfer From Floors to Surfaces
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-20', 'size': 127308, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-22T10:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Lab personnel processing cultures blinded to the study group'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-24', 'studyFirstSubmitDate': '2021-06-12', 'studyFirstSubmitQcDate': '2021-06-12', 'lastUpdatePostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contamination of a composite of high-touch surfaces, personal items, socks/feet, bedding, and hands', 'timeFrame': '48 hours', 'description': 'Cultures for MS2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Floor', 'Bacteriophage MS2', 'Contamination', 'Environment', 'Healthcare-associated pathogens'], 'conditions': ['Transmission, Other/Miscellaneous']}, 'referencesModule': {'references': [{'pmid': '35997135', 'type': 'DERIVED', 'citation': 'Haq MF, Alhmidi H, Redmond SN, Cadnum JL, Silva SY, Wilson BM, Donskey CJ. A randomized trial to determine whether wearing slippers reduces transfer of bacteriophage MS2 from floors to patients and surfaces in hospital rooms. Infect Control Hosp Epidemiol. 2023 Apr;44(4):670-673. doi: 10.1017/ice.2021.475. Epub 2022 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine if wearing slippers will reduce transfer of bacteriophage MS2 from hospital room floors to surfaces in the room and hands of patients. Subjects are randomized to wear slippers versus standard care and cultures are collected at 24 and 48 hours to assess transfer of bacteriophage MS2 from the floor to high-touch surfaces, personal items, bedding, socks or feet, and hands of patients.', 'detailedDescription': 'The goal of this study is to determine if wearing slippers will reduce transfer of bacteriophage MS2 from hospital room floors to surfaces in the room and hands of patients. Hospitalized patients are enrolled and randomized to wear slippers any time they are out of bed versus standard care. Bacteriophage MS2 is inoculated onto a site on the floor between the patient bed and the bathroom. Cultures are collected at 24 and 48 hours to assess transfer of bacteriophage MS2 from the floor to high-touch surfaces (bed rail, bedside table, telephone, call button), personal items, bedding, socks or feet, and hands of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients of 18 years of age or older\n* Ambulatory\n* Able to demonstrate an understanding of study procedures\n\nExclusion Criteria:\n\n* Unable or unwilling to fulfill study requirements.\n* Expected length of stay less than 48 hours\n* Any patient deemed not suitable for study participation at the discretion of the study investigator'}, 'identificationModule': {'nctId': 'NCT04935892', 'briefTitle': 'Slippers to Reduce Transfer From Floors to Surfaces', 'organization': {'class': 'FED', 'fullName': 'Louis Stokes VA Medical Center'}, 'officialTitle': 'Impact of Wearing Slippers on Transfer of Bacteriophage MS2 From Floors in Patient Rooms to Bedding and Surfaces', 'orgStudyIdInfo': {'id': '17044-H34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slippers', 'description': 'Patients wear slippers any time they are out of bed with a goal of avoiding any contact between socks/feet and the floor', 'interventionNames': ['Behavioral: Slippers']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients receive standard care with no intervention'}], 'interventions': [{'name': 'Slippers', 'type': 'BEHAVIORAL', 'description': 'Patients in the intervention group wear slippers when out of bed', 'armGroupLabels': ['Slippers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland VA Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Curtis J Donskey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland VA Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Available 6/22/21 through 6/22/24', 'ipdSharing': 'YES', 'description': 'We will provide de-identified individual participant data to those who provide a request in writing.', 'accessCriteria': 'Written request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louis Stokes VA Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Curtis Donskey', 'investigatorAffiliation': 'Louis Stokes VA Medical Center'}}}}