Local subcutaneous gentamicin to prevent surgical site infections after elective cesarean section
Official title: Local Subcutaneous Administration of Gentamicin for the Prevention of Surgical Site Infection Following Elective Cesarean Section: A Randomized Controlled Pilot Study.
Run by Western Galilee Hospital-Nahariya · NCT07311395 · Data updated 2026-11-12
This trial tests whether injecting a small dose of gentamicin under the skin at the incision lowers the chance of surgical site infection after an elective cesarean delivery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Western Galilee Hospital-Nahariya Government |
| Locations | 1 site (Nahariya) |
| Status | Recruiting |
| Started | December 8, 2025 |
| Main results expected | January 7, 2027 |
| Study ends | January 7, 2027 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT07311395 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 or older scheduled for an elective cesarean at ≥24 weeks gestation who are eligible for standard antibiotic prophylaxis and can provide informed consent and attend 30-day follow-up.
✕Probably not a fit
Patients with known allergy to aminoglycosides, those already requiring therapeutic antibiotics, on immunosuppressive therapy, with active infection, or undergoing non-elective/emergency cesarean are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will compare women undergoing elective cesarean delivery who receive local subcutaneous gentamicin at the incision in addition to standard antibiotic prophylaxis with women who receive standard prophylaxis alone. The primary outcome is the rate of superficial and deep surgical site infections within 30 days after delivery. Secondary safety and postoperative outcomes include wound healing, fever, need for additional antibiotic treatment, and hospital readmission. Participants are adults (≥18 years) at Western Galilee Hospital with planned 30-day follow-up.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative wound infections and lower the need for extra antibiotics or readmission after elective cesarean delivery.
How similar studies have gone: Similar local antibiotic application approaches have been used in other surgical settings with mixed results, and use specifically for elective cesarean wound infiltration is relatively limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Able to provide informed consent. Exclusion Criteria: * 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. * Active infection or clinical condition requiring antibiotic treatment. * Inability or unwillingness to comply with study procedures or follow-up.
Where it's running
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Western Galilee Hospital-Nahariya
Nahariya, Israel Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.