Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-03-09 @ 5:49 AM
Study NCT ID:
NCT02526667
Status:
COMPLETED
Last Update Posted:
2020-09-28
First Post:
2015-08-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C010882', 'term': 'chlorhexidine gluconate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'research@evic.ro', 'phone': '40 21 335 70 90', 'title': 'Dr. Olsavszky', 'organization': 'Evic Romania'}, 'certainAgreement': {'otherDetails': 'Confidential information based on contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CHG Cloth Abdomen', 'description': 'CHG, 3 min application to abdomen', 'otherNumAtRisk': 284, 'otherNumAffected': 0, 'seriousNumAtRisk': 284, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle Abdomen', 'description': 'Vehicle 3 min application to abdomen', 'otherNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Comparator CHG Abdomen', 'description': 'CHG comparator applied to abdomen', 'otherNumAtRisk': 281, 'otherNumAffected': 0, 'seriousNumAtRisk': 281, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'CHG Cloth Groin', 'description': 'CHG, 3 min application to groin', 'otherNumAtRisk': 290, 'otherNumAffected': 0, 'seriousNumAtRisk': 290, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Vehicle Groin', 'description': 'Vehicle 3 min application to groin', 'otherNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Comparator CHG Groin', 'description': 'CHG comparator applied to groin', 'otherNumAtRisk': 294, 'otherNumAffected': 0, 'seriousNumAtRisk': 294, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '281', 'groupId': 'OG004'}, {'value': '294', 'groupId': 'OG005'}]}, {'units': 'Sites', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '314', 'groupId': 'OG004'}, {'value': '294', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'CHG 3 Min Abdomen', 'description': 'single application on abdomen'}, {'id': 'OG001', 'title': 'CHG 3 Min Groin', 'description': 'single application on groin'}, {'id': 'OG002', 'title': 'Vehicle Abdomen', 'description': 'single application on abdomen'}, {'id': 'OG003', 'title': 'Vehicle Groin', 'description': 'single application on groin'}, {'id': 'OG004', 'title': 'Comparator CHG Abdomen', 'description': 'single application on abdomen'}, {'id': 'OG005', 'title': 'Comparator CHG Groin', 'description': 'single application on groin'}], 'classes': [{'title': '10 min', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}]}]}, {'title': '8 hours', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '98', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 minutes, 6 hours, 8 hours', 'description': 'Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.', 'unitOfMeasure': 'Percent of sites', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sites', 'denomUnitsSelected': 'Sites', 'populationDescription': 'Number of participants involved in the analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CHG Cloth', 'description': 'CHG, 3 min application'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'Vehicle 3 min application'}, {'id': 'FG002', 'title': 'Comparator CHG', 'description': 'CHG comparator application'}], 'periods': [{'title': 'Abdomen', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '568', 'numSubjects': '284'}, {'groupId': 'FG001', 'numUnits': '112', 'numSubjects': '56'}, {'groupId': 'FG002', 'numUnits': '562', 'numSubjects': '281'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '307', 'numSubjects': '284'}, {'groupId': 'FG001', 'numUnits': '59', 'numSubjects': '56'}, {'groupId': 'FG002', 'numUnits': '314', 'numSubjects': '281'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '261', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '53', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '248', 'numSubjects': '0'}]}]}, {'title': 'Groin', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '580', 'numSubjects': '290'}, {'groupId': 'FG001', 'numUnits': '112', 'numSubjects': '56'}, {'groupId': 'FG002', 'numUnits': '588', 'numSubjects': '294'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '291', 'numSubjects': '290'}, {'groupId': 'FG001', 'numUnits': '55', 'numSubjects': '56'}, {'groupId': 'FG002', 'numUnits': '294', 'numSubjects': '294'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '289', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '57', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '294', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Sites', 'recruitmentDetails': 'Upon achieving sufficient microbial growth prior to product application on either the abdomen, groin or both abdomen and groin regions,sites of the participant were then randomized to receive one or two products for evaluation for up to 4 sites. Differences in the number of participants is based on microbial qualification.', 'preAssignmentDetails': 'The sites of the participant were tested for microbial activity after product application. In some instances, more than one product could have been applied to a participant but only one product per site (groin and/or abdomen sites). Up to 4 sites could be treated: 1) both groin and abdomen, 2) only the groin or 3) only the abdomen.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CHG, Vehicle, Comparator CHG', 'description': 'Single applications of products. 3 min application for CHG and Vehicle. Comparator CHG applied according to instructions.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '315', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '69'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '182', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '158', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Romania', 'categories': [{'measurements': [{'value': '340', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2015-08-16', 'resultsFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2015-08-16', 'lastUpdatePostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-01', 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin', 'timeFrame': '10 minutes, 6 hours, 8 hours', 'description': 'Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preoperative surgical skin preparation'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.', 'detailedDescription': 'Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post Chlorhexidine Gluconate (CHG) application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or Females\n* 18 years of age or older\n* Signed informed consent\n* Good Health\n* Six inches of abdomen and groin areas without tattoos, or skin disorders\n\nExclusion Criteria:\n\n* Dermatological Conditions\n* Sensitivity to latex\n* Sensitivity to CHG'}, 'identificationModule': {'nctId': 'NCT02526667', 'briefTitle': 'Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medline Industries'}, 'officialTitle': 'Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation', 'orgStudyIdInfo': {'id': 'R15-029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine Gluconate Cloth', 'description': '2% CHG, single application', 'interventionNames': ['Drug: Chlorhexidine gluconate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Cloth', 'description': 'Excipients on cloth', 'interventionNames': ['Other: Vehicle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Chlorhexidine gluconate solution', 'description': 'Dynahex 2% CHG', 'interventionNames': ['Drug: DynaHex-2']}], 'interventions': [{'name': 'Chlorhexidine gluconate', 'type': 'DRUG', 'otherNames': ['CHG'], 'description': '2% CHG solution on cloth', 'armGroupLabels': ['Chlorhexidine Gluconate Cloth']}, {'name': 'DynaHex-2', 'type': 'DRUG', 'otherNames': ['CHG 2%'], 'description': '2% CHG solution', 'armGroupLabels': ['Active Chlorhexidine gluconate solution']}, {'name': 'Vehicle', 'type': 'OTHER', 'otherNames': ['Control'], 'description': 'Excipients of CHG product only', 'armGroupLabels': ['Vehicle Cloth']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucharest', 'country': 'Romania', 'facility': 'Bio High Tech SRL', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'R Olsavcszky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S.C. BIO HIGH TECH S.R.L.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data to be shared with FDA.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medline Industries', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}