Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-23 @ 3:38 AM
Study NCT ID:
NCT01867567
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2013-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Bandage Removal Post-Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2013-05-26', 'studyFirstSubmitQcDate': '2013-06-03', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound Disruption', 'timeFrame': '5 - 7 days'}], 'secondaryOutcomes': [{'measure': 'Wound Infection', 'timeFrame': '5 - 7 days'}, {'measure': 'Patient satisfaction', 'timeFrame': '5 - 7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cesarean', 'bandage removal', 'infection', 'disruption', 'satisfaction', 'patient satisfaction'], 'conditions': ['Wound Disruption', 'Wound Infection']}, 'descriptionModule': {'briefSummary': 'Women undergoing their first second or third cesarean section will be randomized into two groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days for both groups. The incision will be inspected at the time of staple removal. The 2 groups will be compared for incision disruption and infection. Also, the women will be asked about their satisfaction for time of bandage removal.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of 18 to 44\n* elective cesarean section, primary or repeat\n* low risk pregnancy\n\nExclusion Criteria:\n\n* under the age of 18 and above the age of 44\n* diabetes, preeclampsia or other pregnancy complications\n* unable or unwilling to give informed consent\n* chorioamnionitis\n* BMI over 35\n* more than 3 cesareans'}, 'identificationModule': {'nctId': 'NCT01867567', 'briefTitle': 'Early Bandage Removal Post-Cesarean Delivery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'Early Bandage Removal Post-Cesarean Delivery', 'orgStudyIdInfo': {'id': 'CSBandage'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '6 Hours', 'description': 'Removal of bandage after 6 hours', 'interventionNames': ['Procedure: abdominal bandage']}, {'type': 'ACTIVE_COMPARATOR', 'label': '24 hours', 'description': 'removal of bandage after 24 hours', 'interventionNames': ['Procedure: abdominal bandage']}], 'interventions': [{'name': 'abdominal bandage', 'type': 'PROCEDURE', 'armGroupLabels': ['24 hours', '6 Hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Safed', 'country': 'Israel', 'facility': 'Ziv Medical center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician', 'investigatorFullName': 'David Peleg', 'investigatorAffiliation': 'Ziv Hospital'}}}}