Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT03645967
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2018-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kajorgenson@medline.com', 'phone': '2243014670', 'title': 'Keri Jorgenson', 'organization': 'Medline Industries, LP'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participant Duration: Participant had an IUC inserted during their hospital stay, through study completion, an average of 4 days with 61 being the maximum number of days.', 'description': "If the condition of the participant's perineal skin and soft-tissue deteriorates unexpectedly, per the PI's interpretation, or if there is a new condition that the PI determines is not related to the baseline health condition but could be related to the use of the study product, it will be recorded as an AE.", 'eventGroups': [{'id': 'EG000', 'title': 'ReadyCleanse for IUC', 'description': 'ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used.\n\nReadyCleanse Cloths: ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode.', 'otherNumAtRisk': 9872, 'deathsNumAtRisk': 9872, 'otherNumAffected': 0, 'seriousNumAtRisk': 9872, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Infections Per 1,000 (CAUTI) Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9872', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ReadyCleanse for IUC', 'description': 'ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used.\n\nReadyCleanse Cloths: ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8429', 'groupId': 'OG000', 'lowerLimit': '0.6080', 'upperLimit': '1.1685'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'Incidence Rate for CAUTIs per 1,000 Catheter days', 'unitOfMeasure': 'infection per 1,000 catheter days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of "Health Care Providers Responding to Health Care Provider Feedback Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ReadyCleanse for IUC', 'description': 'ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used.\n\nReadyCleanse Cloths: ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode.'}], 'classes': [{'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Begins 3 months after start date. Time to take survey is approximately 10 minutes.', 'description': 'Healthcare provider feedback survey will be delivered to all staff that have utilized the ReadyCleanse cloths for indwelling urinary catheter care and maintenance. Purpose of the survey is to investigate healthcare provider preference and opinion of device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Health Care Providers'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ReadyCleanse for IUC', 'description': 'ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used.\n\nReadyCleanse Cloths: ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9891'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9891'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9891', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ReadyCleanse for IUC', 'description': 'ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used.\n\nReadyCleanse Cloths: ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '50'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4540', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5351', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '457', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '530', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7105', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '204', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1587', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9891', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-19', 'size': 1398697, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-20T11:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intervention in the standard of care for indwelling urinary catheter care and maintenance.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9891}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2018-07-26', 'resultsFirstSubmitDate': '2021-10-22', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-28', 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infections Per 1,000 (CAUTI) Days', 'timeFrame': '16 months', 'description': 'Incidence Rate for CAUTIs per 1,000 Catheter days'}], 'secondaryOutcomes': [{'measure': 'Number of "Health Care Providers Responding to Health Care Provider Feedback Survey', 'timeFrame': 'Begins 3 months after start date. Time to take survey is approximately 10 minutes.', 'description': 'Healthcare provider feedback survey will be delivered to all staff that have utilized the ReadyCleanse cloths for indwelling urinary catheter care and maintenance. Purpose of the survey is to investigate healthcare provider preference and opinion of device.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Catheter-Associated Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'Superiority study evaluating the efficacy of a prepackaged cleansing cloth and standardizing cleansing protocol vs. previous standard-of-care for catheter care and maintenance.', 'detailedDescription': 'A superiority study evaluating the efficacy of a complete cleansing system composed of 5 prepackaged, moistened cloths with a standardized cleaning method compared to the previous standard-of-care for catheter care and maintenance. The primary objective is to investigate if the implementation of prepackaged cleansing cloths with a standardized cleaning protocol for all indwelling urinary catheter (IUC) care and maintenance provides a reduction in CAUTIs. The ReadyCleanse complete cleansing system will replace the previous standard-of-care. The ReadyCleanse intervention will be compared to the previous standard-of-care retrospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any adult patient who requires an IUC to be placed during admission to one of the four study hospitals\n\nExclusion Criteria:\n\n* patients \\<18 years of age\n* patients whose entire hospital stay occurs in: pediatric unit, psychiatric unit, labor \\& delivery or postpartum units, and emergency room'}, 'identificationModule': {'nctId': 'NCT03645967', 'briefTitle': 'Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medline Industries'}, 'officialTitle': 'Efficacy of Meatal and Perineal Care With a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol in Reducing Catheter-Associated Urinary Tract Infections in Acute-Care Hospitals', 'orgStudyIdInfo': {'id': 'R17-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ReadyCleanse for IUC', 'description': 'ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used.', 'interventionNames': ['Device: ReadyCleanse Cloths']}], 'interventions': [{'name': 'ReadyCleanse Cloths', 'type': 'DEVICE', 'description': 'ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode.', 'armGroupLabels': ['ReadyCleanse for IUC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem - Evanston', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60026', 'city': 'Glenview', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem - Glenbrook', 'geoPoint': {'lat': 42.06975, 'lon': -87.78784}}, {'zip': '60035', 'city': 'Highland Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem - Highland Park', 'geoPoint': {'lat': 42.18169, 'lon': -87.80034}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem - Skokie', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}], 'overallOfficials': [{'name': 'Kamal S Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endeavor Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medline Industries', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}