Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
Study NCT ID:
NCT03412734
Status:
TERMINATED
Last Update Posted:
2021-01-11
First Post:
2018-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vaginal Preparation Prior to Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002710', 'term': 'Chlorhexidine'}, {'id': 'D007455', 'term': 'Iodine'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006219', 'term': 'Halogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Catrina_Crisp@trihealth.com', 'phone': '513-463-4300', 'title': 'Catrina Crisp, MD MSc', 'organization': 'TriHealth Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 week post-op', 'eventGroups': [{'id': 'EG000', 'title': 'Chlorhexidine Group', 'description': 'Chlorhexidine: Chlorhexidine preparation solutions', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Iodine Group', 'description': 'Iodine: Iodine-based preparation solutions', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Contamination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Group', 'description': 'Chlorhexidine: Chlorhexidine preparation solutions'}, {'id': 'OG001', 'title': 'Iodine Group', 'description': 'Iodine: Iodine-based preparation solutions'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.6', 'ciLowerLimit': '3.02', 'ciUpperLimit': '37.34', 'pValueComment': 'p-value is adjusted for baseline BV (Bacterial Vaginosis)', 'groupDescription': 'We hypothesized that chlorhexidine would have a lower bacterial count compared to iodine. Our sample size was calculated to be 71 patients per arm to detect a 22% difference in cultures defined as contaminated at 90 minutes from surgical preparation.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 minutes from initial preparation', 'description': 'Contamination is defined as having \\>5000 bacteria within a culture', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Use participants with cultures at 90 minutes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chlorhexidine Group', 'description': 'Patients randomized to the Chlorhexidine group will undergo pre-surgical vaginal aseptic preparation using 4% Chlorhexidine preparation solutions.'}, {'id': 'FG001', 'title': 'Iodine Group', 'description': 'Those patients randomized to the povidone-iodine group will have their pre-surgical vaginal aseptic preparation performed using 10% povidone-iodine solution.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Incorrect labeling of samples', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Exclusion criteria - patient receiving Flagyl for treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '6 patients were excluded (3 - not randomized at the day of surgery; 3 - missing study consent).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chlorhexidine Group', 'description': 'Chlorhexidine: Chlorhexidine preparation solutions'}, {'id': 'BG001', 'title': 'Iodine Group', 'description': 'Iodine: Iodine-based preparation solutions'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Bacterial Vaginosis (BV) positive', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Bacterial Vaginosis was identified through a modified Nugent method (Nugent RP et al. 1991), and Nugent score points was awarded based on three morphotypes:\n\nmedium to large gram positive rods, small gram negative or variable rods, curved gram negative or variable rods.\n\nEach of these morphotypes was assigned a score based on their initial count, and the three morphotypes is then added, and any score \\>7 is consistent bacterial vaginosis, and a score \\<3 is normal flora.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-20', 'size': 277011, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-22T14:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'whyStopped': 'The institutional review board recommended the study stop enrollment prior to achieving its initial sample size for patient safety.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-06', 'studyFirstSubmitDate': '2018-01-22', 'resultsFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-26', 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Contamination', 'timeFrame': '90 minutes from initial preparation', 'description': 'Contamination is defined as having \\>5000 bacteria within a culture'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '1706728', 'type': 'RESULT', 'citation': 'Nugent RP, Krohn MA, Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol. 1991 Feb;29(2):297-301. doi: 10.1128/jcm.29.2.297-301.1991.'}, {'pmid': '34333502', 'type': 'DERIVED', 'citation': 'Hill AM, Pauls RN, Basil J, Tam T, Yook E, Shatkin-Margolis A, Kleeman S, Yeung J, Aldrich E, Crisp CC. Chlorhexidine Versus Iodine for Vaginal Preparation Before Hysterectomy: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2022 Feb 1;28(2):77-84. doi: 10.1097/SPV.0000000000001066.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial to determine the influence of chlorhexidine gluconate surgical/topical antiseptic solutions on the bacterial environment of the vagina during hysterectomy and compare that to the effect of standard iodine-based preparations on the same.', 'detailedDescription': 'Postoperative infection remains the most common complication of surgical procedures in gynecology. Historically, 30-40% of patients undergoing a hysterectomy develop a post-operative infection. The initiation of antibiotic prophylaxis for appropriate surgical procedures was a significant advancement in the prevention of surgical site infection.\n\nAntibiotic prophylaxis has been standardized and universally implemented. A remaining variable is the method of aseptic preparation of the vagina with substantial variation of technique being reported even within institutions.\n\nThe most recent Committee Opinion by the American College of Obstetricians and Gynecologists concludes there is insufficient evidence to render a strong recommendation for either povidone-iodine or chlorhexidine as the ideal agent for surgical preparation of the vagina and that further evidence is necessary.\n\nPovidone-iodine solution has been considered the standard for aseptic surgical preparation of the vagina for decades and is the only solution approved by the FDA for vaginal use. There are however specific qualities of the solution that suggest it may be less than ideal for use in the vagina. More contemporary efforts have begun to focus on chlorhexidine as a more ideal agent for aseptic efforts in surgical preparation of the vagina.\n\nThe purpose of our study is to use a randomized controlled trial to determine if chlorhexidine gluconate surgical preparation maintains a lower rate of contamination to the surgical field.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing total vaginal, laparoscopic assisted vaginal, total laparoscopic, or robotic-assisted laparoscopic hysterectomy by a physician at Cincinnati Urogynecology Associates or Tri-State Gynecology Oncology TriHealth Inc.\n* Concomitant procedures such as vaginal vault suspension, suburethral sling, cystoscopy, enterocele repair, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy, staging procedures, lymph node sampling and other indicated procedures will be included\n* English speaking\n* Ability to provide consent\n\nExclusion Criteria:\n\n* Unwillingness to participate in the study\n* Non English speaking\n* Patients that do not undergo a hysterectomy\n* Reported allergy to iodine or chlorhexidine preparation solutions\n* Patients undergoing planned debulking surgery for ovarian, fallopian tube or primary peritoneal cancers\n* Current infection necessitating hysterectomy\n* Active sepsis, pelvic abscess or pelvic inflammatory disease'}, 'identificationModule': {'nctId': 'NCT03412734', 'briefTitle': 'Vaginal Preparation Prior to Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Is Chlorhexidine Vaginal Preparation Prior to Hysterectomy Superior to Iodine in Reducing Bacterial Count; a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '17-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine group', 'interventionNames': ['Drug: Chlorhexidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iodine group', 'interventionNames': ['Drug: Iodine']}], 'interventions': [{'name': 'Chlorhexidine', 'type': 'DRUG', 'description': 'Chlorhexidine preparation solutions', 'armGroupLabels': ['Chlorhexidine group']}, {'name': 'Iodine', 'type': 'DRUG', 'description': 'Iodine-based preparation solutions', 'armGroupLabels': ['Iodine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Catrina Crisp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TriHealth - Cincinnati Urogynecology Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}