Local Subcutaneous Gentamicin for Prevention of Surgical Site Infection After Elective Cesarean Section
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gentamicin, Standard antibiotic prophylaxis, Placebo (saline).
- Who it may be relevant to
- Registry conditions: Surgical Site Infection. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Local Subcutaneous Administration of Gentamicin for the Prevention of Surgical Site Infection Following Elective Cesarean Section: A Randomized Controlled Pilot Study.
Overview
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
- Drug Gentamicin
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. - Drug Standard antibiotic prophylaxis
Participants receive standard systemic antibiotic prophylaxis according to institutional protocol. - Other Placebo (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.
Primary outcome measures
- Composite wound complication within 30 days after cesarean delivery [Time frame: within 30 days after cesarean section]
Secondary outcome measures (1)
- Surgical site infection within 30 days after cesarean delivery [Time frame: 30 days after cesarean delivery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Israel · 1 center
- Western Galilee Hospital-Nahariya — Nahariya
Identifiers
NCT: NCT07311395 · 0177-25-NHR