Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-21 @ 1:31 PM
Study NCT ID:
NCT02348866
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2015-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacterial Contamination on Obstetric Resident Surgical Scrubs
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': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2015-01-23', 'studyFirstSubmitQcDate': '2015-01-27', 'lastUpdatePostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference in bacterial contamination between scrubs donned at home and those put on in the hospital, when location of laundering is considered (as determined by (CFU/cm2)', 'timeFrame': '4 days', 'description': '4 days of randomization per subject'}], 'secondaryOutcomes': [{'measure': 'Prevalence of antibiotic resistant Staphylococcus aureus on surgical scrubs in the obstetric setting', 'timeFrame': '4 days', 'description': '4 days of randomization per subject'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bacterial Contamination']}, 'descriptionModule': {'briefSummary': 'This study will determine if there is a difference in bacterial contamination (CFU/cm2) between obstetric resident surgical scrubs donned at home and those donned at the hospital.', 'detailedDescription': 'An area of potential provider-to-patient contamination, and therefore intervention, is in health care worker attire and laundering practices. For providers who work in the operating room or labor \\& delivery suites, this uniform usually comprises hospital-issued surgical scrubs. To the best of our knowledge, no study has measured the difference in bacterial contamination on surgical scrubs vis-a-vis the two variables most directly affected by hospital policies for surgical attire: site of scrub laundering and site where scrubs were first put on. In addition, no study has measured the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting. Our primary objective is to measure the difference in bacterial contamination (CFU/cm2) between home-laundered/home-donned scrubs ("home/home," group 1), hospital-laundered/home-donned scrubs ("hospital/home," group 2), home-laundered/hospital-donned scrubs ("home/hospital," group 3), and hospital-laundered/hospital-donned scrubs ("hospital/hospital," group 4) in the obstetric setting. Our secondary objective is to determine the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ob-gyn residents assigned to labor and delivery during the day on one of seven rotation blocks\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02348866', 'briefTitle': 'Bacterial Contamination on Obstetric Resident Surgical Scrubs', 'organization': {'class': 'OTHER', 'fullName': 'Prisma Health-Upstate'}, 'officialTitle': 'Bacterial Contamination on Obstetric Resident Surgical Scrubs: a Randomized Trial', 'orgStudyIdInfo': {'id': 'Pro#00041187'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'home laundered/home-donned', 'interventionNames': ['Other: method of laundering and donning scrubs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Hospital laundered/home-donned', 'interventionNames': ['Other: method of laundering and donning scrubs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'Home laundered/hospital donned', 'interventionNames': ['Other: method of laundering and donning scrubs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4', 'description': 'Hospital laundered/hospital donned', 'interventionNames': ['Other: method of laundering and donning scrubs']}], 'interventions': [{'name': 'method of laundering and donning scrubs', 'type': 'OTHER', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kacey Y Eichelberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prisma Health-Upstate'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prisma Health-Upstate', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}