Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:19 AM
Study NCT ID:
NCT07311395
Status:
RECRUITING
Last Update Posted:
2025-12-31
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Subcutaneous Gentamicin for Prevention of Surgical Site Infection After Elective Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005839', 'term': 'Gentamicins'}], 'ancestors': [{'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative surgical site infection', 'timeFrame': 'within 30 days after cesarean section'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Site Infection']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether local subcutaneous administration of gentamicin reduces the incidence of surgical site infection (SSI) following elective cesarean section. The study will also assess the safety of local gentamicin administration. The main questions this study aims to answer are:\n\n* Does local subcutaneous administration of gentamicin reduce the rate of superficial and deep surgical site infections within 30 days after elective cesarean delivery?\n* Are there differences between groups in postoperative complications, including wound healing, fever, need for additional antibiotic treatment, or hospital readmission?\n\nResearchers will compare women who receive local subcutaneous gentamicin at the surgical site in addition to standard antibiotic prophylaxis to women who receive standard antibiotic prophylaxis alone.\n\nParticipants will:\n\n* Undergo an elective cesarean section according to standard clinical practice\n* Receive either local subcutaneous gentamicin administration or no local antibiotic administration, in addition to standard systemic antibiotic prophylaxis\n* Be followed clinically for signs of surgical site infection and other postoperative complications during hospitalization and at follow-up visits up to 30 days after surgery'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Eligibility is limited to individuals of the female biological sex due to the nature of elective cesarean delivery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 years and older. Undergoing elective cesarean section. Gestational age \\>= 24 weeks. Planned postoperative follow-up of 30 days. Eligible for standard antibiotic prophylaxis according to institutional protocol.\n\nAble to provide informed consent.\n\nExclusion Criteria:\n\n* Known allergy of hypersensitivity to aminoglycosides. Known allergy of hypersensitivity to systemic antibiotic prophylaxis agents. Current or planned use of immunomodulatory or immunosuppressive therapy. Requirement for therapeutic ( non- prophylactic) antibiotic treatment at the time of surgery.\n\nActive infection or clinical condition requiring antibiotic treatment. Inability or unwillingness to comply with study procedures or follow-up.'}, 'identificationModule': {'nctId': 'NCT07311395', 'briefTitle': 'Local Subcutaneous Gentamicin for Prevention of Surgical Site Infection After Elective Cesarean Section', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Western Galilee Hospital-Nahariya'}, 'officialTitle': 'Local Subcutaneous Administration of Gentamicin for the Prevention of Surgical Site Infection Following Elective Cesarean Section: A Randomized Controlled Pilot Study.', 'orgStudyIdInfo': {'id': '0177-25-NHR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Local subcutaneous gentamicin', 'interventionNames': ['Drug: Gentamicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard antibiotc prophylaxis', 'interventionNames': ['Drug: Standard antibiotic prophylaxis']}], 'interventions': [{'name': 'Gentamicin', 'type': 'DRUG', 'description': 'Participants receive a single local subcutaneous administration of gentamicin at the surgical site during elective cesarean section, in addition to standard systemic antibiotic prophylaxis, to reduce postoperative surgical site infection.', 'armGroupLabels': ['Local subcutaneous gentamicin']}, {'name': 'Standard antibiotic prophylaxis', 'type': 'DRUG', 'description': 'Participants receive standard systemic antibiotic prophylaxis according to institutional protocol.', 'armGroupLabels': ['Standard antibiotc prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nahariya', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'NadirG@gmc.gov.il', 'phone': '+972-50-2061077'}], 'facility': 'Western Galilee Hospital-Nahariya', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Nadir Ganem', 'investigatorAffiliation': 'Western Galilee Hospital-Nahariya'}}}}