Surgical Site Infection
Conditions
Brief 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
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.
Participants receive standard systemic antibiotic prophylaxis according to institutional protocol.
OTHERPlacebo (saline)
Participants receive a single local subcutaneous administration of placebo (saline) at the surgical site during elective cesarean section, in addition to standard systemic antibiotic prophylaxis.
Sponsors
Western Galilee Hospital-Nahariya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite wound complication within 30 days after cesarean delivery | within 30 days after cesarean section | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Surgical site infection within 30 days after cesarean delivery | 30 days after cesarean delivery |
Countries
Israel
Outcome results
None listed