Clinical Trial

Local Subcutaneous Gentamicin for Prevention of Surgical Site Infection After Elective Cesarean Section

Recruiting
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Summary
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: * Does local subcutaneous administration of gentamicin reduce the rate of superficial and deep surgical site infections within 30 days after elective cesarean delivery? * Are there differences between groups in postoperative complications, including wound healing, fever, need for additional antibiotic treatment, or hospital readmission? Researchers 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. Participants will: * Undergo an elective cesarean section according to standard clinical practice * Receive either local subcutaneous gentamicin administration or no local antibiotic administration, in addition to standard systemic antibiotic prophylaxis * 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
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-06-27
notable Primary completion pushed: 2026-01-07 -> 2027-01-07 2026-06-27
minor Completion pushed: 2026-01-07 -> 2027-01-07 2026-06-27
Trial Details
NCT Number NCT07311395
Lead Sponsor Western Galilee Hospital-Nahariya
Conditions Surgical Site Infection
Enrollment 100 participants
Start Date 2025-12-08
Primary Completion 2027-01-07 (estimated)
Study Completion 2027-01-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-26