Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-06 @ 11:38 AM
Study NCT ID:
NCT04220294
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2020-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2020-01-05', 'studyFirstSubmitQcDate': '2020-01-05', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection rate.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Surgical site infection rate.'}], 'secondaryOutcomes': [{'measure': 'Rate of re-admission due to surgical site infection.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'rate of re-admission within 6 weeks postpartum due to surgical site infection.'}, {'measure': 'Rate of postoperative febrile morbidity.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Rate of maternal body temperature \\> 38°C.'}, {'measure': 'Rate of maternal fever.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Rate of maternal fever in degrees celsius.'}, {'measure': 'Duration of maternal fever.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Duration of maternal fever in days.'}, {'measure': 'Rate of antibiotic use for the treatment of surgical site infection.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Rate of antibiotic use for the treatment of surgical site infection.'}, {'measure': 'Cesraean section-to-surgical site infection time interval.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Cesraean section-to-surgical site infection time interval in days.'}, {'measure': 'Rate of bacteremia.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Rate of bacteremia.'}, {'measure': 'Rate of sepsis.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Rate of sepsis.'}, {'measure': 'Post-operative duration of hospitalization.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Post-operative duration of hospitalization in days.'}, {'measure': 'Postoperative pain.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Postoperative pain based on the visual analogue scale score ranging from 0-10.'}, {'measure': 'Rate of postoperative anemia.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Rate of a hemoglobin level of under 10 gr/dL'}, {'measure': 'Blood transfusion rates.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Blood transfusion rates (recommended to patients with a postpartum hemoglobin level of under 7 gr/dL or between 7-8 gr/dL if anemia related symptoms are present)'}, {'measure': 'Breastfeeding rates.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Breastfeeding rates.'}, {'measure': 'rate of voiding problems.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Rate of need for either intermittent catheterization or 24-hour foley insertion to void'}, {'measure': 'Venous thromboembolism rates.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Venous thromboembolism rates.'}, {'measure': 'Rate of admission to intensive care unit.', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Rates of admission to intensive care unit'}, {'measure': 'Maternal death rate', 'timeFrame': 'From admission up to 6 weeks postpartum.', 'description': 'Maternal death rate.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suture Line Infection']}, 'descriptionModule': {'briefSummary': 'A comparison of the rate of surgical site infections after cesarean section depending on the type of suture used for subcutaneous closure-continuous versus interrupted.', 'detailedDescription': 'Patients at term that are candidates for elective cesarean section will receive an explanation regarding the study and sign informed consent. Patients will then be divided randomly to one of 2 treatment groups based on the type of subcutaneous tissue closure:\n\n1. Interrupted sutures.\n2. Continuous sutures. Information regarding medical and obstetric history will be collected for each patient.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant women undergoing elective cesarean section.\n* Subcutaneous tissue layer\\>2 centimeter according to ultrasound.\n\nExclusion Criteria:\n\n* Non-elective CS.\n* Fever during the 48 hours prior to surgery.\n* Antibiotic treatment during the 48 hours prior to surgery.\n* Inability to give informed consent.\n* Preterm delivery (\\< 37 weeks' gestation).\n* Fetal death.\n* Known fetal anomalies or placental abnormalities.\n* Immunosuppressive conditions."}, 'identificationModule': {'nctId': 'NCT04220294', 'briefTitle': 'Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Surgical Site Infection Rate After Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.', 'orgStudyIdInfo': {'id': '0621-19-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interrupted sutures', 'description': 'Subcutaneous tissue closure by interrupted sutures.', 'interventionNames': ['Procedure: Subcutaneous tissue closure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous sutures', 'description': 'Subcutaneous tissue closure by continuous sutures.', 'interventionNames': ['Procedure: Subcutaneous tissue closure']}], 'interventions': [{'name': 'Subcutaneous tissue closure', 'type': 'PROCEDURE', 'description': 'Subcutaneous tissue closure with 2-0 vicryl suture.', 'armGroupLabels': ['Continuous sutures', 'Interrupted sutures']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam healthcare campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Roy Lauterbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Healthcare Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'ROY LAUTERBACH MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}