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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWestern Galilee Hospital-Nahariya

About this trial

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 criteria

Qualifiers

Women aged 18 years and older.

Undergoing elective cesarean section.

Gestational age >= 24 weeks.

Planned postoperative follow-up of 30 days.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Gentamicin
  • Standard antibiotic prophylaxis
  • Placebo (saline)

Treatment groups

100 Participants
are divided into 2 treatment groups