Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT07311395

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

Led by Western Galilee Hospital-Nahariya · Updated on 2025-12-31

100

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 years and older
  • Undergoing elective cesarean section
  • Gestational age of 24 weeks or more
  • Planned postoperative follow-up of 30 days
  • Eligible for standard antibiotic prophylaxis according to institutional protocol
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Known allergy or hypersensitivity to aminoglycosides
  • Known allergy or 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Western Galilee Hospital-Nahariya

Nahariya, Israel

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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