Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01509950
Status:
COMPLETED
Last Update Posted:
2019-03-04
First Post:
2012-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}, {'id': 'C095495', 'term': 'glycolide E-caprolactone copolymer'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'agirsen@stanford.edu', 'phone': '6507255720', 'title': 'Research Operations Manager', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 weeks after cesarean delivery.', 'eventGroups': [{'id': 'EG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Level of Pain on a Scale During the Post-operative Hospitalization Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'OG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '3.4'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.0'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-operative day 3 or 4.', 'description': 'Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Level of Pain on a Scale at 6 Weeks Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'OG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-operative week 6', 'description': 'Pain level on a scale (Mosby visual analog pain scale) of 1 (no pain) to 10 (worst pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Wound Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'OG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-operative week 6', 'description': 'Wound complications include conditions like infection, seroma/hematoma and dehiscence', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Level of Patient Satisfaction to the Wound Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'OG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-operative day 3 or 4', 'description': 'Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'OG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}], 'timeFrame': 'Post-operative week 6', 'description': 'Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no patients that had data available for analysis for "staples" and "prolene non-absorbable sutures" study arms.'}, {'type': 'SECONDARY', 'title': 'Time From Skin Incision to the Skin Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'OG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}], 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000', 'lowerLimit': '46.0', 'upperLimit': '61.0'}, {'value': '56.5', 'groupId': 'OG001', 'lowerLimit': '54.0', 'upperLimit': '62.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day of cesarean delivery (up to 8 hours)', 'description': 'Measured in minutes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Needed for the Suture Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'OG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}], 'classes': [{'categories': [{'measurements': [{'value': '79.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '84.5'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-operative day 3 or 4', 'description': 'Measured in seconds', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Level of Patient's Satisfaction to the Cosmesis of the Wound", 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'OG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '10.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '7.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-operative week 6', 'description': 'Measured on a scale of 0 (very unsatisfied to the cosmesis) to 10 (very satisfied to the cosmesis)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Level of Patient's Overall Patient Satisfaction to the Type of Closure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'OG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '8.5'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '6.25', 'upperLimit': '8.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-operative day 1', 'description': 'Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Level of Patient's Overall Patient Satisfaction to the Type of Closure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'OG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-operative day 3 or 4', 'description': 'Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Level of Patient's Overall Patient Satisfaction to the Type of Closure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'OG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}], 'timeFrame': 'Post-operative week 6', 'description': 'Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients had data available for the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'FG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}, {'id': 'FG002', 'title': 'Absorbable Sutures', 'description': 'Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl.\n\nAbsorbable Sutures: Absorbable sutures for closure of cesarean skin incision'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment into the first two arms (Staples and Prolene non-absorbable sutures) occurred through May 2013. The study protocol was modified in July 2014 and the third arm of the study, absorbable sutures, was added, however, no recruitment occurred after this modification.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Staples', 'description': 'Use of staples for skin closure at cesarean section\n\nStaples: Staples for closure of cesarean section skin incision'}, {'id': 'BG001', 'title': 'Prolene Non-absorbable Sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section\n\nProlene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'groupId': 'BG000', 'lowerLimit': '24.5', 'upperLimit': '38.5'}, {'value': '33.5', 'groupId': 'BG001', 'lowerLimit': '31.5', 'upperLimit': '34.5'}, {'value': '33.3', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '36.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', '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': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'No enrollment occurred after adding the "absorbable sutures" study arm.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2013-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-01', 'studyFirstSubmitDate': '2012-01-05', 'resultsFirstSubmitDate': '2018-11-01', 'studyFirstSubmitQcDate': '2012-01-10', 'lastUpdatePostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-01', 'studyFirstPostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Pain on a Scale During the Post-operative Hospitalization Period', 'timeFrame': 'Post-operative day 3 or 4.', 'description': 'Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)'}], 'secondaryOutcomes': [{'measure': 'Level of Pain on a Scale at 6 Weeks Postpartum', 'timeFrame': 'Post-operative week 6', 'description': 'Pain level on a scale (Mosby visual analog pain scale) of 1 (no pain) to 10 (worst pain).'}, {'measure': 'Count of Participants With Wound Complications', 'timeFrame': 'Post-operative week 6', 'description': 'Wound complications include conditions like infection, seroma/hematoma and dehiscence'}, {'measure': 'Level of Patient Satisfaction to the Wound Appearance', 'timeFrame': 'Post-operative day 3 or 4', 'description': 'Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)'}, {'measure': 'Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum', 'timeFrame': 'Post-operative week 6', 'description': 'Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)'}, {'measure': 'Time From Skin Incision to the Skin Closure', 'timeFrame': 'Day of cesarean delivery (up to 8 hours)', 'description': 'Measured in minutes'}, {'measure': 'Time Needed for the Suture Removal', 'timeFrame': 'Post-operative day 3 or 4', 'description': 'Measured in seconds'}, {'measure': "Level of Patient's Satisfaction to the Cosmesis of the Wound", 'timeFrame': 'Post-operative week 6', 'description': 'Measured on a scale of 0 (very unsatisfied to the cosmesis) to 10 (very satisfied to the cosmesis)'}, {'measure': "Level of Patient's Overall Patient Satisfaction to the Type of Closure", 'timeFrame': 'Post-operative day 1', 'description': 'Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)'}, {'measure': "Level of Patient's Overall Patient Satisfaction to the Type of Closure", 'timeFrame': 'Post-operative day 3 or 4', 'description': 'Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)'}, {'measure': "Level of Patient's Overall Patient Satisfaction to the Type of Closure", 'timeFrame': 'Post-operative week 6', 'description': 'Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy', 'Cesarean Section']}, 'descriptionModule': {'briefSummary': 'Currently different materials are used to close the skin after a cesarean delivery, including absorbable suture, non-absorbable suture and staples. It is not known what is the best choice of material to close the skin after a cesarean section, but commonly staples or dissolvable suture is used. Recently plastic surgeons have found that non-dissolvable suture may have a better cosmetic outcome than staples. The investigators hope to learn if there is a difference in pain both at suture/staple removal and 6 weeks postoperatively between Prolene suture, Absorbable suture (monocryl or vicryl) or staples. The investigators also plan to look for differences in wound complications and patient satisfaction, as well as operating and removal times. This knowledge will be important in helping practitioners choose the closure technique at cesarean delivery.', 'detailedDescription': "Patients who meet inclusion criteria will be approached upon admission to Labor and Delivery. A study staff member will describe the study and offer participation. If a patient agrees to participate, she will sign research protocol and HIPAA consent forms and receive a copy of these forms. The patient's chart will be flagged, indicating that she is a study participant. The patient's prenatal care and labor and delivery will be managed by her physician per standard of care at the physician's discretion, including routine surgical preparation and procedures.\n\nWhen a participating patient is scheduled for a cesarean section, she will be randomized to Arm 1 (Staples) or Arm 2 (Prolene) or Arm 3 (Monocryl or Vicryl absorbable suture). She will be treated as per standard of care and her cesarean section performed per physician discretion. After the closure of the fascial layer, the surgeons will follow the same protocol for each study participant, including wound irrigation with warm sterile saline and reapproximation of the subcutaneous layer if greater than 2.0 cm in depth (per standard of care). The patient in Arm 1 will have skin closure with staples. The patient in Arm 2 will have skin closure with 2-0 Prolene in a subcuticular fashion. The patient in Arm 3 will have skin closure with monocryl or vicryl in the standard fashion. Patients in Arms 1 and 2 will have their closure material removed at the physician's discretion per the standard of care at post-operative day 3 or 4.\n\nPain level will be assessed on the first and third or fourth day after surgery and again at six weeks."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women undergoing primary or repeat cesarean section\n* Maternal age greater than or equal to 18 years of age\n* Gestational age greater than or equal to 34 weeks\n* Elective and non-elective cesarean section\n\nExclusion Criteria:\n\n* Type 1 or Type 2 diabetes\n* BMI greater than 35\n* Pre-operative diagnosis of chorioamnionitis\n* History of drug or alcohol abuse\n* Contraindication to NSAIDs\n* Chronic pain diagnosis\n* Narcotic use prior to pregnancy\n* Maternal age less than 18 years of age\n* General anesthesia\n* Chorioamnionitis, clinical suspicion of chorioamnionitis, or risk factors for chorioamnionitis (membrane rupture greater than 18 hours, GBS positive status)\n* Vertical skin incision'}, 'identificationModule': {'nctId': 'NCT01509950', 'briefTitle': 'Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study', 'orgStudyIdInfo': {'id': '22389'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Staples', 'description': 'Use of staples for skin closure at cesarean section', 'interventionNames': ['Procedure: Staples']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prolene non-absorbable sutures', 'description': 'Use of Prolene non-absorbable sutures for skin closure at cesarean section', 'interventionNames': ['Procedure: Prolene non-absorbable sutures']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Absorbable sutures', 'description': 'Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl.', 'interventionNames': ['Procedure: Absorbable Sutures']}], 'interventions': [{'name': 'Staples', 'type': 'PROCEDURE', 'otherNames': ['Reflex one skin stapler 35 wide. Manufactured by Conmed'], 'description': 'Staples for closure of cesarean section skin incision', 'armGroupLabels': ['Staples']}, {'name': 'Prolene non-absorbable sutures', 'type': 'PROCEDURE', 'otherNames': ['Prolene 2-0 18 inch on FS needle. Manufactured by Ethicon'], 'description': 'Prolene non-absorbable sutures for closure of cesarean skin incision', 'armGroupLabels': ['Prolene non-absorbable sutures']}, {'name': 'Absorbable Sutures', 'type': 'PROCEDURE', 'otherNames': ['Monocryl or Vicryl. Manufactured by Ethicon'], 'description': 'Absorbable sutures for closure of cesarean skin incision', 'armGroupLabels': ['Absorbable sutures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Lucile Packard Childrens Hospital', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Natali Aziz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Natali Aziz', 'investigatorAffiliation': 'Stanford University'}}}}