Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 9:02 PM
Study NCT ID:
NCT01216761
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2010-10-06
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010882', 'term': 'chlorhexidine gluconate'}, {'id': 'D011206', 'term': 'Povidone-Iodine'}], 'ancestors': [{'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laraine@med.umich.edu', 'phone': '734-936-5205', 'title': 'Laraine Washer, MD', 'organization': 'University of Michigan Health System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'It is possible for subjects to have multiple blood culture sets obtained during the study.Thus, the # of blood culture sets will not equal the # of subjects. Also, cross-over assignment occurred at the hospital floor level - not the subject level.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CHG Then PI Then IT', 'description': '2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG\n\n10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI\n\nIodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT', 'otherNumAtRisk': 1421, 'otherNumAffected': 0, 'seriousNumAtRisk': 1421, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IT Then CHG Then PI', 'description': 'Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT\n\n2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG\n\n10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI', 'otherNumAtRisk': 1410, 'otherNumAffected': 0, 'seriousNumAtRisk': 1410, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PI Then IT Then CHG', 'description': '10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI\n\nIodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT\n\n2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG', 'otherNumAtRisk': 1379, 'otherNumAffected': 0, 'seriousNumAtRisk': 1379, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Culture Contamination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1429', 'groupId': 'OG000'}, {'value': '1450', 'groupId': 'OG001'}, {'value': '1480', 'groupId': 'OG002'}]}, {'units': 'Blood culture sets', 'counts': [{'value': '4388', 'groupId': 'OG000'}, {'value': '4230', 'groupId': 'OG001'}, {'value': '4286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Gluconate (CHG_', 'description': '2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG'}, {'id': 'OG001', 'title': 'Iodine Tincture (IT)', 'description': 'Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT'}, {'id': 'OG002', 'title': 'Povidone Iodine (PI)', 'description': '10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 days', 'description': 'A culture set was considered contaminated if it yielded growth of typical skin contaminants including aerobic gram positive rods, Lactobacillus sp, Propionibacterium acnes, Micrococcus sp, Bacillus sp (not B. anthracis or B. cereus), coag negative Staphylococcus, Neisseria sp (not N. meningitides or N. gonorrhoeae), or gamma-hemolytic streptococci (not Enterococcus sp) from only 1 of 2 or more blood culture sets obtained from different sites.', 'unitOfMeasure': 'blood culture sets', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Blood culture sets', 'denomUnitsSelected': 'Blood culture sets', 'populationDescription': 'Intention to treat analyses. Please note: it is possible for a single patient to have multiple blood culture sets obtained throughout the study. Therefore, number of blood culture sets will differ from the number of unique patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CHG Then PI Then IT', 'description': '2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG\n\n10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI\n\nIodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT'}, {'id': 'FG001', 'title': 'IT Then CHG Then PI', 'description': 'Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT\n\n2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG\n\n10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI'}, {'id': 'FG002', 'title': 'PI Then IT Then CHG', 'description': '10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI\n\nIodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT\n\n2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'It is possible for the same patient to appear in multiple sequences throughout the study.', 'groupId': 'FG000', 'numSubjects': '1421'}, {'comment': 'It is possible for the same patient to appear in multiple sequences throughout the study.', 'groupId': 'FG001', 'numSubjects': '1410'}, {'comment': 'It is possible for the same patient to appear in multiple sequences throughout the study.', 'groupId': 'FG002', 'numSubjects': '1379'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'It is possible for the same patient to appear in multiple sequences throughout the study.', 'groupId': 'FG000', 'numSubjects': '1421'}, {'comment': 'It is possible for the same patient to appear in multiple sequences throughout the study.', 'groupId': 'FG001', 'numSubjects': '1410'}, {'comment': 'It is possible for the same patient to appear in multiple sequences throughout the study.', 'groupId': 'FG002', 'numSubjects': '1379'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Please note: it is possible for a single patient to have multiple blood culture sets obtained throughout the study. Therefore, number of blood culture sets will differ from the number of unique patients.\n\nAlso, cross-over assignment occurred at the hospital floor level - not the individual subject level.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3879', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Population'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '17.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3879', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender data were not collected for this study', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3879}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-09', 'studyFirstSubmitDate': '2010-10-06', 'resultsFirstSubmitDate': '2011-10-07', 'studyFirstSubmitQcDate': '2010-10-06', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-03', 'studyFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Culture Contamination', 'timeFrame': '5 days', 'description': 'A culture set was considered contaminated if it yielded growth of typical skin contaminants including aerobic gram positive rods, Lactobacillus sp, Propionibacterium acnes, Micrococcus sp, Bacillus sp (not B. anthracis or B. cereus), coag negative Staphylococcus, Neisseria sp (not N. meningitides or N. gonorrhoeae), or gamma-hemolytic streptococci (not Enterococcus sp) from only 1 of 2 or more blood culture sets obtained from different sites.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bacteremia', 'Blood culture', 'Contamination', 'Antiseptic agents'], 'conditions': ['Bacteremia']}, 'referencesModule': {'references': [{'pmid': '23221187', 'type': 'DERIVED', 'citation': 'Washer LL, Chenoweth C, Kim HW, Rogers MA, Malani AN, Riddell J 4th, Kuhn L, Noeyack B Jr, Neusius H, Newton DW, Saint S, Flanders SA. Blood culture contamination: a randomized trial evaluating the comparative effectiveness of 3 skin antiseptic interventions. Infect Control Hosp Epidemiol. 2013 Jan;34(1):15-21. doi: 10.1086/668777. Epub 2012 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'Background: Contaminated blood cultures result in unnecessary antibiotic use, increased length of stay, and additional laboratory tests, all of which increase healthcare costs. While the optimal skin antisepsis agent for reducing blood culture contamination is not known, the cost of various agents differs substantially.\n\nObjective: To determine the relative rates of blood culture contamination for 3 skin antisepsis interventions - 10% povidone iodine aqueous solution (PI), 2% iodine tincture (IT) and 2% chlorhexidine gluconate in 70% isopropyl alcohol (CHG) - when used by dedicated phlebotomy teams to obtain peripheral blood cultures in adult non-ICU medical and surgical patients.', 'detailedDescription': 'A group-randomized crossover trial was conducted to test the null hypothesis of no difference in blood culture contamination rates among 3 antiseptic skin preparations. The sequence of 3 different antiseptic treatments was randomly assigned to 3 separate hospital floors, therefore in this trial cross-over occurred at the hospital floor level (not the individual patient level).\n\nAlso, it is possible for subjects to have multiple blood culture sets obtained during the study. Thus, the number of blood culture sets will not equal the number of unique subjects in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient on general medical, surgical, and cardiology floors\n* Receipt of a peripheral blood draw for blood culture collection\n* Blood draw performed by phlebotomy team\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01216761', 'briefTitle': 'A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Blood Culture Contamination: A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions', 'orgStudyIdInfo': {'id': 'N010316 - 1932.II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CHG then PI then IT', 'description': 'Skin antisepsis prior to any peripheral blood culture collection on Floor A was performed with CHG for 3 months, followed by PI for 3 months, followed by IT for 3 months. Each 3 month intervention period was separated by a one month wash out period where data regarding blood culture contamination was not collected.\n\n2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG\n\n10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI\n\nIodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT', 'interventionNames': ['Drug: Iodine tincture', 'Drug: Chlorhexidine gluconate', 'Drug: Povidone iodine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IT then CHG then PI', 'description': 'Skin antisepsis prior to any peripheral blood culture collection on Floor B was performed with iodine tincture for 3 months, followed by Chlorhexidine gluconate for 3 months, followed by povidone iodine for 3 months. Each 3 month intervention period was separated by a one month wash out period where data regarding blood culture contamination was not collected.\n\nIodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT\n\n2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG\n\n10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI', 'interventionNames': ['Drug: Iodine tincture', 'Drug: Chlorhexidine gluconate', 'Drug: Povidone iodine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PI then IT then CHG', 'description': 'Skin antisepsis prior to any peripheral blood culture collection on Floor C was performed with povidone iodine for 3 months, followed by iodine tincture for 3 months, followed by chlorhexidine gluconate for 3 months. Each 3 3 month intervention period was separated by a one month wash out period where data regarding blood culture contamination was not collected.\n\n10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI\n\nIodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT\n\n2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG', 'interventionNames': ['Drug: Iodine tincture', 'Drug: Chlorhexidine gluconate', 'Drug: Povidone iodine']}], 'interventions': [{'name': 'Iodine tincture', 'type': 'DRUG', 'description': 'Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS)', 'armGroupLabels': ['CHG then PI then IT', 'IT then CHG then PI', 'PI then IT then CHG']}, {'name': 'Chlorhexidine gluconate', 'type': 'DRUG', 'description': '2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS)', 'armGroupLabels': ['CHG then PI then IT', 'IT then CHG then PI', 'PI then IT then CHG']}, {'name': 'Povidone iodine', 'type': 'DRUG', 'description': '10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)', 'armGroupLabels': ['CHG then PI then IT', 'IT then CHG then PI', 'PI then IT then CHG']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Laraine L. Washer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue Cross Blue Shield of Michigan Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Internal Medicine', 'investigatorFullName': 'Laraine Washer', 'investigatorAffiliation': 'University of Michigan'}}}}