Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
Study NCT ID:
NCT02907892
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2016-09-16
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'isak0023@umn.edu', 'phone': '6513345982', 'title': 'Dr. Rachel Vogel', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Standard cesarean section surgical technique per surgeon preference', 'otherNumAtRisk': 277, 'otherNumAffected': 0, 'seriousNumAtRisk': 277, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Glove Change', 'description': 'Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure\n\nGlove change: Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section', 'otherNumAtRisk': 276, 'otherNumAffected': 0, 'seriousNumAtRisk': 276, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Wound Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard cesarean section surgical technique per surgeon preference'}, {'id': 'OG001', 'title': 'Glove Change', 'description': 'Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure\n\nGlove change: Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 8 weeks following cesarean section', 'description': 'Occurence of at least one of the following: wound seroma, wound hematoma, wound infection, skin separation of at least 1cm, or other incisional separation or abnormality requiring a bedside procedure to fix', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with follow-up data (at least one postpartum visit within 8 weeks of delivery)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Standard cesarean section surgical technique per surgeon preference'}, {'id': 'FG001', 'title': 'Glove Change', 'description': 'Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure\n\nGlove change: Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '277'}, {'groupId': 'FG001', 'numSubjects': '276'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '236'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '40'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Standard cesarean section surgical technique per surgeon preference'}, {'id': 'BG001', 'title': 'Glove Change', 'description': 'Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure\n\nGlove change: Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.7', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '30.6', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', '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 and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 554}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-08', 'studyFirstSubmitDate': '2016-09-16', 'resultsFirstSubmitDate': '2017-12-08', 'studyFirstSubmitQcDate': '2016-09-16', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-08', 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Wound Complication', 'timeFrame': 'Within 8 weeks following cesarean section', 'description': 'Occurence of at least one of the following: wound seroma, wound hematoma, wound infection, skin separation of at least 1cm, or other incisional separation or abnormality requiring a bedside procedure to fix'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wound Complications']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial to determine whether changing of gloves by the surgical team during cesarean section may decrease post-operative infectious morbidity and wound complications', 'detailedDescription': 'This was a randomized, single-blind controlled trial of women who underwent cesarean section at Healthpartners Regions Hospital. Potential participants were identified during routine obstetrical care of singleton pregnancies at Regions Hospital, at the time that cesarean section was decided as the route of delivery by patient and provider. Patients were excluded if the cesarean section was performed emergently. Randomization occurred in the operating room during preparation for cesarean section; nursing staff drew a computer generated allocation card from a stack placed within an envelope in the room. Patients assigned to the control group underwent cesarean section with standard surgical technique at the discretion of the attending surgeon. Patients assigned to the glove change group underwent cesarean section in which the surgical team - surgeon, assistant, and scrub nurse - replaced their outer surgical gloves with a new sterile pair of gloves prior to abdominal closure. Abdominal closure was considered to begin with closure of the peritoneum, if performed, otherwise with closure of the abdominal fascia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant woman with singleton pregnancy and shared decision making with provider resulting in plan for cesarean section\n\nExclusion Criteria:\n\n* Severe immunocompromise (AIDS) or emergent nature of cesarean section'}, 'identificationModule': {'nctId': 'NCT02907892', 'briefTitle': 'Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications:', 'orgStudyIdInfo': {'id': '1416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard cesarean section surgical technique per surgeon preference'}, {'type': 'EXPERIMENTAL', 'label': 'Glove Change', 'description': 'Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure', 'interventionNames': ['Procedure: Glove change']}], 'interventions': [{'name': 'Glove change', 'type': 'PROCEDURE', 'description': 'Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section', 'armGroupLabels': ['Glove Change']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Regions Hospital', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Jonathan Scrafford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'HealthPartners Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}