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
Women aged 18 years and older.
Undergoing elective cesarean section.
Gestational age >= 24 weeks.
Planned postoperative follow-up of 30 days.
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.
Parallel
Gentamicin
DrugParticipants 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.
Standard antibiotic prophylaxis
DrugParticipants receive standard systemic antibiotic prophylaxis according to institutional protocol.
Placebo (saline)
Other interventionParticipants receive a single local subcutaneous administration of placebo (saline) at the surgical site during elective cesarean section, in addition to standard systemic antibiotic prophylaxis.
Composite wound complication within 30 days after cesarean delivery
Occurrence of one or more postoperative wound complications within 30 days, including SSI, wound dehiscence, seroma requiring drainage, hematoma requiring intervention, wound-related antibiotic treatment, wound-related emergency department visit, or wound-related readmission.
Surgical site infection within 30 days after cesarean delivery
Click on the lead sponsor to view all of their trials.
