Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06454227
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2024-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subcutaneous Lavage in Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-06-08', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical site infection', 'timeFrame': '30 days after surgery', 'description': 'SSI infection rates'}], 'secondaryOutcomes': [{'measure': 'hospital stay', 'timeFrame': '30 days after surgery', 'description': 'length of hospital stay'}, {'measure': 'wound healing', 'timeFrame': '30 days after surgery', 'description': 'assessment of the healing according to Southampton criteria: presence of inflammation, erythema or discharge'}, {'measure': 'postpartum fever', 'timeFrame': '30 days after surgery', 'description': 'fever recording'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Site Infection']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if antiseptic washing prior to skin closure during cesarean section reduces rates of surgical site infection.\n\nintraoperative washing is a common practice in other surgical fields and several studies have shown efficacy in reducing postoperative infection rates. no randomized control trial has tested this intervention during cesarean section.\n\nThe main questions we aim to answer are:\n\nDoes subcutaneous antiseptic washing reduce the rates of surgical site infection? Does antiseptic washing improve scar healing? Does antiseptic washing reduce hospital stay, postpartum fever rates and readmission cases?\n\nResearchers will compare subcutaneous antiseptic washing to no intervention to see if surgical site infection rates reduce\n\nParticipants will:\n\nconsent to participate in the trial Visit the postpartum clinic 30 days after surgery'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'pregnant women undergoing cesarean delivery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women undergoing cesarean delivery\n\nExclusion Criteria:\n\n* pregnant women undergoing vaginal delivery'}, 'identificationModule': {'nctId': 'NCT06454227', 'briefTitle': 'Subcutaneous Lavage in Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Antiseptic Washing Prior to Skin Closure During Cesarean Delivery- a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'WASHCD-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Subcutan lavage', 'description': 'Subcutaneous washing with antiseptic solution: Chlorhexidine gluconate 0.2%', 'interventionNames': ['Procedure: Subcutaneous washing']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'no lavage', 'description': 'No subcutaneous washing', 'interventionNames': ['Procedure: no subcutaneous washing']}], 'interventions': [{'name': 'Subcutaneous washing', 'type': 'PROCEDURE', 'description': 'subcutaneous washing with chlorhexidine gluconate prior to skin closure', 'armGroupLabels': ['Subcutan lavage']}, {'name': 'no subcutaneous washing', 'type': 'PROCEDURE', 'description': 'no washing', 'armGroupLabels': ['no lavage']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '00 972 2 6777572'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}