NCT07311395

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

Local Subcutaneous Administration of Gentamicin for the Prevention of Surgical Site Infection Following Elective Cesarean Section: A Randomized Controlled Pilot Study.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Gentamicin	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.
DRUG	Standard antibiotic prophylaxis	Participants receive standard systemic antibiotic prophylaxis according to institutional protocol.

Timeline

• Start date: 2025-12-08
• Primary completion: 2026-01-07
• Completion: 2026-01-07
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: Israel