Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT04449705
Status:
WITHDRAWN
Last Update Posted:
2021-06-15
First Post:
2020-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality Assessment of a Multifaceted, Perioperative Infection Control Bundle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'At the start of each case, the technician will obtain an OR PathTrac kit and will fill out required card indicating the OR number, the surgery date, and the type of surgery. The cards will be placed back into the kit. Sample collection will be directed via use of the kit. The first sample is the adjustable pressure-limiting valve and agent dial of the machine before patient entry (measures terminal cleaning), then provider (attending and assistant) hands after they enter but before patient interaction, then the provider nose and mouth after induction of anesthesia and patient stabilization, then provider hands, then same environmental sites, then provider sites again, then stopcock.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'whyStopped': "Hospital didn't use perioperative infection control bundle so study wasn't applicable.", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-10', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative transmission of S. aureus', 'timeFrame': '24 hours', 'description': 'S. aureus transmission event'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Transmission']}, 'descriptionModule': {'briefSummary': 'Surgical site infections increase patient morbidity and healthcare costs. The Centers for Disease Control and Prevention emphasizes improved basic preventive measures to reduce bacterial transmission and infections for patients undergoing surgery. We conducted a previous study that showed our treatment bundle is highly effective.\n\nOur current study planned to examine patterns/rate of S. aureus transmission to improve feedback widespread implementation of the perioperative infection prevention program at Iowa.\n\nThe purpose of this study is to assess the fidelity of the set of interventions in controlling perioperative S. aureus and to provide data feedback via surveillance involving epidemiology of transmission for system optimization.', 'detailedDescription': 'The operating room schedule will be reviewed each day by the research assistant.\n\nAt the start of each case, the technician will obtain an OR PathTrac kit and will fill out required card indicating the OR number, the surgery date, and the type of surgery. The cards will be placed back into the kit. Sample collection will be directed via use of the kit. The first sample is the adjustable pressure-limiting valve and agent dial of the machine before patient entry (measures terminal cleaning), then provider (attending and assistant) hands after they enter but before patient interaction, then the provider nose and mouth after induction of anesthesia and patient stabilization, then provider hands, then same environmental sites, then provider sites again, then stopcock.\n\nA transmission event will be defined as detection of S. aureus pathogens among 2 distinct, epidemiologically-related reservoirs within a surveillance unit. The software platform will process transmission dynamics in order to continually summarize the epidemiology of S. aureus transmission, with results updated daily as case-pair data is continually entered into the program. This information will be continually displayed to identify the most common reservoir of origin, the most common transmission locations (vectors), and involvement of key portals of entry (stopcocks). These will become improvement targets with feedback provided via automated failure mode analysis reports. The research assistant will use the reports to continually optimize the interventions during the observational period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing surgery at the University of Iowa', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (at least 18 years old) patient undergoing surgery requiring anesthesia and placement of a peripheral and/or central intravenous catheter.\n\nExclusion Criteria:\n\n* \\<18 years old, Shellfish, iodine, chlorhexidine allergies, no anesthesia and/or placement of peripheral and/or central intravenous catheter required'}, 'identificationModule': {'nctId': 'NCT04449705', 'briefTitle': 'Quality Assessment of a Multifaceted, Perioperative Infection Control Bundle', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Quality Assessment of a Multifaceted, Perioperative Infection Control Bundle', 'orgStudyIdInfo': {'id': '202006248'}}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Randyt W Loftus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '2 years from study completion', 'ipdSharing': 'YES', 'description': 'Request for information must be submitted as a proposal for PI review. Not before 2 years. Use subject to PI review', 'accessCriteria': 'A written proposal submitted to PI for review'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Randy Loftus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Randy Loftus', 'investigatorAffiliation': 'University of Iowa'}}}}