Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-01 @ 3:54 PM
Study NCT ID:
NCT00987402
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2009-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephan.harbarth@hcuge.ch', 'phone': '+41-22-372.3357', 'title': 'Stephan Harbarth MD', 'organization': 'University Hospital, Geneva'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Most cases, post-discharge monitoring was not conducted by outpatient clinic visits following a standard protocol, some data was not collected, and routine microbiologic cultures were not obtained.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Plain Soap and Water', 'description': 'Surgical hand preparation with plain soap and water', 'otherNumAtRisk': 1596, 'otherNumAffected': 0, 'seriousNumAtRisk': 1596, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Alcohol Based Hand Rubs', 'description': 'Surgical hand preparation with alcohol based alcohol hand rub', 'otherNumAtRisk': 1537, 'otherNumAffected': 0, 'seriousNumAtRisk': 1537, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Cost of Hand Preparation Agent', 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Average weekly costs were estimated for the plain soap and water used each week in the operating room as well as for the procurement, preparation and dispensing of the alcohol-based handrub to enable a comparison between the two study arms.', 'unitOfMeasure': 'Euros', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1682', 'groupId': 'OG000'}, {'value': '1635', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Plain Soap and Water', 'description': 'Surgical hand preparation with plain soap and water'}, {'id': 'OG001', 'title': 'Alcohol Based Hand Rubs', 'description': 'Surgical hand preparation with alcohol based alcohol hand rub'}], 'classes': [{'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Power calculations assumed a 2-sided alpha error of 0.05 and a power of 80%. We performed power calculations using a statistical model for a cluster-randomized trial with 8, 10 or 12 clusters including 6 operating rooms each, with different levels of reduction (10%, 30%, 50%) in surgical site infection rates in the active intervention period. By reaching a sample size of 3133 patients, the study was powered to detect a 30% reduction effect in SSI rates, from 10% to 7%.', 'statisticalMethod': 'generalized estimating equation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 days post-operatively', 'description': '255 (8.1%) patients developed SSIs. Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2009-10'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Plain Soap and Water', 'description': 'Surgical hand preparation with plain soap and water'}, {'id': 'FG001', 'title': 'Alcohol Based Hand Rubs', 'description': 'Surgical hand preparation with alcohol based alcohol hand rub'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'January 2007, with crossover every 2 months', 'groupId': 'FG000', 'numSubjects': '1682'}, {'comment': 'January 2007 with crossover every 2 months', 'groupId': 'FG001', 'numSubjects': '1635'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '86 patients did not have some data, and could not be evaluated', 'groupId': 'FG000', 'numSubjects': '1596'}, {'comment': '98 patients did not have sufficient data', 'groupId': 'FG001', 'numSubjects': '1537'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '98'}]}], 'dropWithdraws': [{'type': 'Insufficient data entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '98'}]}]}], 'recruitmentDetails': 'Patients undergoing surgery at AIC Kijabe Hospital recruited between January 2007 to November 2007', 'preAssignmentDetails': 'Patients who declined consent for participation were excluded, as were those undergoing a second procedure within 2 weeks of the first.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1682', 'groupId': 'BG000'}, {'value': '1635', 'groupId': 'BG001'}, {'value': '3317', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Plain Soap and Water', 'description': 'Surgical hand preparation with plain soap and water'}, {'id': 'BG001', 'title': 'Alcohol Based Hand Rubs', 'description': 'Surgical hand preparation with alcohol based alcohol hand rub'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '23', 'groupId': 'BG000'}, {'value': '29', 'spread': '19', 'groupId': 'BG001'}, {'value': '29', 'spread': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Participants', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '964', 'groupId': 'BG000'}, {'value': '908', 'groupId': 'BG001'}, {'value': '1872', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '718', 'groupId': 'BG000'}, {'value': '727', 'groupId': 'BG001'}, {'value': '1445', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kenya', 'categories': [{'measurements': [{'value': '1682', 'groupId': 'BG000'}, {'value': '1635', 'groupId': 'BG001'}, {'value': '3317', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-20', 'studyFirstSubmitDate': '2009-09-30', 'resultsFirstSubmitDate': '2009-10-07', 'studyFirstSubmitQcDate': '2009-09-30', 'lastUpdatePostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-20', 'studyFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Infection', 'timeFrame': '30 days post-operatively', 'description': '255 (8.1%) patients developed SSIs. Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33).'}], 'secondaryOutcomes': [{'measure': 'Cost of Hand Preparation Agent', 'timeFrame': '30 days', 'description': 'Average weekly costs were estimated for the plain soap and water used each week in the operating room as well as for the procurement, preparation and dispensing of the alcohol-based handrub to enable a comparison between the two study arms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Surgery', 'hand scrubbing', 'post-operative infection', 'surgical site infection', 'surgical hand preparation', 'plain soap and water', 'alcohol-based hand rub', 'Cost of surgical hand preparation agent', 'Side effects of use of hand preparation agent'], 'conditions': ['Postoperative Wound Infection']}, 'referencesModule': {'references': [{'pmid': '22297835', 'type': 'DERIVED', 'citation': 'Wood JH, Nthumba PM, Stepita-Poenaru E, Poenaru D. Pediatric surgical site infection in the developing world: a Kenyan experience. Pediatr Surg Int. 2012 May;28(5):523-7. doi: 10.1007/s00383-012-3058-x.'}, {'pmid': '20878941', 'type': 'DERIVED', 'citation': 'Nthumba PM, Stepita-Poenaru E, Poenaru D, Bird P, Allegranzi B, Pittet D, Harbarth S. Cluster-randomized, crossover trial of the efficacy of plain soap and water versus alcohol-based rub for surgical hand preparation in a rural hospital in Kenya. Br J Surg. 2010 Nov;97(11):1621-8. doi: 10.1002/bjs.7213.'}]}, 'descriptionModule': {'briefSummary': 'Surgical site infections (SSI) constitute a significant health-economic and clinical challenge. The investigators conducted a cluster-randomized, cross-over study to compare the efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for surgical hand preparation, to alcohol-based hand rub (ABHR), with SSI rates as the main outcome measure.\n\nA total of 3317 patients undergoing clean and clean-contaminated surgery were included in the study and followed up for 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing clean or clean-contaminated surgery at AIC Kijabe Hospital\n\nExclusion Criteria:\n\n* All patients undergoing contaminated, dirty surgeries and those undergoing repeat procedures within 2 weeks after the initial surgical intervention.\n* Patients who did not consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT00987402', 'briefTitle': 'Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Surgical Site Infections: a Cluster-randomized, Cross-over Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation', 'orgStudyIdInfo': {'id': 'KH-PSW-ABHR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plain soap and water', 'description': 'Surgical hand preparation with plain soap and water', 'interventionNames': ['Other: Plain soap and water (PSW)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alcohol based hand rubs', 'description': 'Surgical hand preparation with alcohol based alcohol hand rub', 'interventionNames': ['Other: Alcohol-based hand rub (ABHR)']}], 'interventions': [{'name': 'Plain soap and water (PSW)', 'type': 'OTHER', 'otherNames': ['Plain bar soap', 'WHO recommended alcohol based hand rub formulation II'], 'description': 'Presence or absence of infection', 'armGroupLabels': ['Plain soap and water']}, {'name': 'Alcohol-based hand rub (ABHR)', 'type': 'OTHER', 'description': 'Presence or absence of infection', 'armGroupLabels': ['Alcohol based hand rubs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00220', 'city': 'Kijabe', 'state': 'Central', 'country': 'Kenya', 'facility': 'Africa Inland Church Kijabe Hospital', 'geoPoint': {'lat': -0.948, 'lon': 36.598}}], 'overallOfficials': [{'name': 'Peter M Nthumba, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AIC Kijabe Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'World Health Organization', 'class': 'OTHER'}, {'name': 'AIC Kijabe Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Peter M. Nthumba, M.D.', 'oldOrganization': 'Africa Inland Church Kijabe Hospital'}}}}