An interventional study of Gentamicin and Standard antibiotic prophylaxis in Surgical Site Infection, sponsored by Western Galilee Hospital-Nahariya. Recruiting at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Western Galilee Hospital-Nahariya · Not applicable, Interventional, and Prevention
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:
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:
Exclusion Criteria:
Participants undergoing elective cesarean section who receive standard systemic antibiotic prophylaxis according to institutional protocol plus a single local subcutaneous administration of gentamicin at the surgical site.
Drug: Gentamicin · Drug: Standard antibiotic prophylaxis
Participants undergoing elective cesarean section who receive standard systemic antibiotic prophylaxis according to institutional protocol plus a single local subcutaneous administration of placebo (saline) at the surgical site.
Drug: Standard antibiotic prophylaxis · Other: Placebo (saline)
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.
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.
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.
Time frame: within 30 days after cesarean section
Surgical site infection within 30 days after cesarean delivery
Time frame: 30 days after cesarean delivery
Plan to share: No
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Western Galilee Hospital-Nahariya