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

RecruitingNAAges 18 Years - anyFemaleWestern Galilee Hospital-Nahariya
NCT07311395 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 elect

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📋 Eligibility rules (as published)
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.
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What it tests

  • Gentamicin
  • Standard antibiotic prophylaxis
  • Placebo (saline)
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Where

1 site
Western Galilee Hospital-Nahariya
Nahariya, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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