RecruitingNot ApplicableNCT07311395

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.


Sponsor

Western Galilee Hospital-Nahariya

Enrollment

100 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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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Interventions

DRUGGentamicin

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.

DRUGStandard antibiotic prophylaxis

Participants receive standard systemic antibiotic prophylaxis according to institutional protocol.


Locations(1)

Western Galilee Hospital-Nahariya

Nahariya, Israel

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NCT07311395


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