Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-03-04 @ 10:50 PM
Study NCT ID:
NCT02095535
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2014-03-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chlorhexidine Drying Time
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C010882', 'term': 'chlorhexidine gluconate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tashya.desilva@cw.bc.ca', 'phone': '604-875-2158', 'title': 'Tashya De Silva', 'organization': "UBC Department of Anesthesia - BC Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "* Small sample size\n* Severe methodological assumptions (i.e. measuring of ChloraPrep drying time, lack of gold standard to assess wetness/dryness\n* Patient's variables could influence wetness\n* No enrollment of high BMI patients with skin folds"}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Study Group', 'description': 'All study participants\n\nChlorhexidine gluconate: antiseptic', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length of Drying Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'All study participants\n\nChlorhexidine gluconate: antiseptic'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'spread': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Chloraprep application', 'description': 'Length of drying time from when Chloraprep solution is applied to skin to when skin is deemed dry.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Group', 'description': 'All study participants\n\nChlorhexidine gluconate: antiseptic'}], 'periods': [{'title': 'Recruitment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Analysis', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Group', 'description': 'All study participants\n\nChlorhexidine gluconate: antiseptic'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-27', 'studyFirstSubmitDate': '2014-03-19', 'resultsFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-27', 'studyFirstPostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Drying Time', 'timeFrame': 'At Chloraprep application', 'description': 'Length of drying time from when Chloraprep solution is applied to skin to when skin is deemed dry.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obstetric patients', 'chloraprep', 'chlorhexidine', 'drying time'], 'conditions': ['Drying Time']}, 'descriptionModule': {'briefSummary': 'Before a patient gets a spinal/epidural, their lower back is cleaned with an antiseptic solution diluted in alcohol called ChloraPrep. ChloraPrep must completely dry before starting the anesthetic procedure. It is not known how much time is needed for the solution to completely dry. The investigators aim to determine this.\n\nAs the ChloraPrep dries, the alcohol is converted into vapour. The investigators will be using a PPBRae 3000 device to detect small amounts of vapours in the air. As the ChloraPrep dries it gives off less and less vapour. The investigators will use this diminishing vapour concentration to determine when drying is complete.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Elective cesarean patients at BC Women's Hospital", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant\n* At full term\n* Due to have a cesarean section under spinal or epidural anesthesia\n* 19 to 40 years of age\n\nExclusion Criteria:\n\n* Allergy to certain antiseptic solutions\n* Not suitable for a spinal/epidural anesthetic\n* Have a significant amount of hair on lower back'}, 'identificationModule': {'nctId': 'NCT02095535', 'acronym': 'Chlorhexidine', 'briefTitle': 'Chlorhexidine Drying Time', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Minimum ChloraPrep Drying Time Before Neuraxial Anesthesia in Elective Cesarean Delivery Patients - Prospective Observational Study', 'orgStudyIdInfo': {'id': 'H14-00623'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'All study participants', 'interventionNames': ['Drug: Chlorhexidine gluconate']}], 'interventions': [{'name': 'Chlorhexidine gluconate', 'type': 'DRUG', 'otherNames': ['Chloraprep'], 'description': 'antiseptic', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Women's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Vit Gunka, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Vit Gunka', 'investigatorAffiliation': 'University of British Columbia'}}}}