Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-01-26 @ 11:46 PM
Study NCT ID:
NCT02294604
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2014-11-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room
Sponsor:
Organization:
Raw JSON
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'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group C', 'description': 'Traditional scrub formation with 4% chlorhexidine\n\nchlorhexidine', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Microorganisms on Hands Before Scrubbing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group R', 'description': 'Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers\n\nethyl alcochol, chlorhexidine and moisturizers'}, {'id': 'OG001', 'title': 'Group I', 'description': 'Traditional scrub formation with 10 % povidone-iodine\n\npovidone-iodine'}, 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'paramType': 'MEAN', 'timeFrame': 'Immediately', 'description': 'The secondary outcome is the duration of hand washing', 'unitOfMeasure': 'Minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group R', 'description': 'Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers\n\nethyl alcochol, chlorhexidine and moisturizers'}, {'id': 'FG001', 'title': 'Group I', 'description': 'Traditional scrub formation with 10 % povidone-iodine\n\npovidone-iodine'}, {'id': 'FG002', 'title': 'Group C', 'description': 'Traditional scrub formation with 4% chlorhexidine\n\nchlorhexidine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did not provide samples for culture', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Culture contamination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group R', 'description': 'Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers\n\nethyl alcochol, chlorhexidine and moisturizers'}, {'id': 'BG001', 'title': 'Group I', 'description': 'Traditional scrub formation with 10 % povidone-iodine\n\npovidone-iodine'}, {'id': 'BG002', 'title': 'Group C', 'description': 'Traditional scrub formation with 4% chlorhexidine\n\nchlorhexidine'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Unknown', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender was not assessed', 'unitOfMeasure': 'participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2014-11-10', 'resultsFirstSubmitDate': '2016-10-12', 'studyFirstSubmitQcDate': '2014-11-15', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-12', 'studyFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microorganisms on Hands Before Scrubbing', 'timeFrame': '2 days after sampling', 'description': 'The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates'}], 'secondaryOutcomes': [{'measure': 'Microorganisms on Hands After Scrubbing', 'timeFrame': '2 days after sampling', 'description': 'The secondary outcomes is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates'}, {'measure': 'Microorganisms on Hands After Surgery', 'timeFrame': '2 days after sampling', 'description': 'The secondary outcomes is the colonies grown on bacterial culture plate'}, {'measure': 'Duration of Hand Washing', 'timeFrame': 'Immediately', 'description': 'The secondary outcome is the duration of hand washing'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hand Disinfection']}, 'descriptionModule': {'briefSummary': 'Hand hygiene is the cornerstone of aseptic techniques to reduce surgical site infection. The traditional surgical antisepsis involves scrubbing the skin with povidone-iodine or chlorhexidine gluconate. Recently, a waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers was developed to provide a comparable antiseptic effect. The investigators perform a randomized controlled trial to compare the antiseptic effectiveness of the waterless hand rubbing, the classic surgical handwashing with povidone-iodine and chlorhexidine solutions.', 'detailedDescription': 'This single centre, randomized trial recruited surgical team members in Taipei Medical University-Shuang Ho Hospital at November 2014. 255 episodes of hand washing are enrolled. The participants are assigned equally to use either a waterless hand rub (Group R), or traditional scrub formation with 10 % povidone-iodine (Group I) and 4% chlorhexidine (Group C). Hand washing time, microorganisms on hands before and after scrubbing is recorded. The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates after hand washing. The secondary outcomes is hand microbial flora after surgery and duration of hand washing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical staff members, both surgeons and scrub nurses\n\nExclusion Criteria:\n\n* Participants were excluded if they were medical or nursing students\n* Allergy to the experimental materials'}, 'identificationModule': {'nctId': 'NCT02294604', 'briefTitle': 'The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Shuang Ho Hospital'}, 'officialTitle': 'The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room', 'orgStudyIdInfo': {'id': '103HCP002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group R', 'description': 'Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers', 'interventionNames': ['Device: ethyl alcochol, chlorhexidine and moisturizers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'Traditional scrub formation with 10 % povidone-iodine', 'interventionNames': ['Device: povidone-iodine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Traditional scrub formation with 4% chlorhexidine', 'interventionNames': ['Device: chlorhexidine']}], 'interventions': [{'name': 'ethyl alcochol, chlorhexidine and moisturizers', 'type': 'DEVICE', 'otherNames': ['Avagard'], 'armGroupLabels': ['Group R']}, {'name': 'chlorhexidine', 'type': 'DEVICE', 'armGroupLabels': ['Group C']}, {'name': 'povidone-iodine', 'type': 'DEVICE', 'armGroupLabels': ['Group I']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ka-Wai Tam, MD, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Taipei Medical University Shuang Ho Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Shuang Ho Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Center for Evidence-Based Health Care', 'investigatorFullName': 'Ka-Wai Tam', 'investigatorAffiliation': 'Taipei Medical University Shuang Ho Hospital'}}}}