Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 1:30 AM
Study NCT ID:
NCT01314703
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2011-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topical Antimicrobial Effectiveness Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019840', 'term': '2-Propanol'}], 'ancestors': [{'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.raeder-devens@carefusion.com', 'phone': '847-454-4939', 'title': 'Jennifer Raeder-Devens', 'organization': 'CareFusion'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Study duration was approximately 21 days per study participant. Overall study duration was 28 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'All subjects received treatment with both the test article and the positive control', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antimicrobial Efficacy Will be Measured by the Change (+/-) in Bacterial Count on the Skin 10 Minutes After a Single Application of Test Material Relative to the Baseline Bacterial Count.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ChloraPrep One Step, 10.5 mL Applicator', 'description': 'All subjects received single application of treatment with ChloraPrep One Step 10.5 mL Applicator on two treatment sites (abdomen and groin).'}, {'id': 'OG001', 'title': '70% Isopropyl Alcohol, 10.5 mL Applicator', 'description': 'All subjects received single application of treatment with 70% Isopropyl Alcohol 10.5 mL Applicator on two treatment sites (abdomen and groin).'}], 'classes': [{'title': '10 minute abdomen', 'categories': [{'measurements': [{'value': '2.8469', 'groupId': 'OG000', 'lowerLimit': '2.6699', 'upperLimit': '3.0238'}, {'value': '2.5328', 'groupId': 'OG001', 'lowerLimit': '2.3559', 'upperLimit': '2.7097'}]}]}, {'title': '10 minute groin', 'categories': [{'measurements': [{'value': '4.038', 'groupId': 'OG000', 'lowerLimit': '3.7438', 'upperLimit': '4.3322'}, {'value': '3.5295', 'groupId': 'OG001', 'lowerLimit': '3.2353', 'upperLimit': '3.8237'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.85', 'ciLowerLimit': '2.66', 'ciUpperLimit': '3.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.089', 'estimateComment': 'ChloraPrep 10 minute abdomen', 'groupDescription': 'Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.038', 'ciLowerLimit': '3.74', 'ciUpperLimit': '4.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.149', 'estimateComment': 'ChloraPrep 10 minute groin', 'groupDescription': 'Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.53', 'ciLowerLimit': '2.36', 'ciUpperLimit': '2.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.089', 'estimateComment': '70%Isopropyl Alcohol 10 minute abdomen', 'groupDescription': 'Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.53', 'ciLowerLimit': '3.24', 'ciUpperLimit': '3.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.149', 'estimateComment': '70% Isopropyl Alcohol 10 minute groin', 'groupDescription': 'Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '10 minutes after single application of test material', 'description': 'the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.', 'unitOfMeasure': 'log 10 colony forming units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '27 subjects were treated with ChloraPrep on the abdomen and groin treatment sites. 26 of the 27 abdomen sites met the qualifying bacterial baseline count and were included in the analysis. 25 of the groin sites met the qualifying bacterial baseline count and were included in the analysis.', 'anticipatedPostingDate': '2011-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ChloraPrep and 70% Isopropyl Alcohol', 'description': 'All subjects received treatment with both the ChloraPrep and 70% Isopropyl Alcohol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'Signed Informed Consent', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'Completed Screen Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Completed Treatment Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Completed Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Excluded Prior to Screening Baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Non Qualified Bacterial Screening Counts', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Discontinued When Enrollment Completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'screen failure and closed enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Recruitment period: March 05-April 04, 2011. Location: Microbiotest,clinical study center', 'preAssignmentDetails': '35 subjects entered pre-screening phase.2 subjects withdrew consent prior to the Screen Visit.33 subjects completed screen baseline.3 subjects did not meet screen baseline criteria.30 subjects qualified for treatment.3 subjects were discontinued prior to treatment because the required number of treatment sites were met. 27 subjects were treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'All subjects received treatment with both the test article and the positive control'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '12.7', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '62'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '12.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2011-03-10', 'resultsFirstSubmitDate': '2012-02-08', 'studyFirstSubmitQcDate': '2011-03-11', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-31', 'studyFirstPostDateStruct': {'date': '2011-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antimicrobial Efficacy Will be Measured by the Change (+/-) in Bacterial Count on the Skin 10 Minutes After a Single Application of Test Material Relative to the Baseline Bacterial Count.', 'timeFrame': '10 minutes after single application of test material', 'description': 'the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Antimicrobial Effectiveness']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep one-Step.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* in good general health\n* have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders.\n\nExclusion Criteria:\n\n* topical or systemic antimicrobial exposure within 14 days prior to Screening Day'}, 'identificationModule': {'nctId': 'NCT01314703', 'briefTitle': 'Topical Antimicrobial Effectiveness Testing', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'Test for Preoperative Skin Preparations', 'orgStudyIdInfo': {'id': '371.1.02.15.11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ChloraPrep One-Step', 'type': 'DRUG', 'description': '10.5 ml applicator preoperative skin preparation'}, {'name': '70% isopropyl alcohol', 'type': 'DRUG', 'otherNames': ['Positive control'], 'description': '10.5 ml applicator'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20164', 'city': 'Sterling', 'state': 'Virginia', 'country': 'United States', 'facility': 'Microbiotest', 'geoPoint': {'lat': 39.00622, 'lon': -77.4286}}], 'overallOfficials': [{'name': 'Muhammad H Bashir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Microbiotest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}