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NCT Number: NCT07311395

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

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

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gentamicin

Drug

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.

Standard antibiotic prophylaxis

Drug

Participants receive standard systemic antibiotic prophylaxis according to institutional protocol.

placebo (saline)

Other

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 outcomes

  1. Composite wound complication within 30 days after cesarean delivery

    Time frame: 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 outcomes

  1. Surgical site infection within 30 days after cesarean delivery

    Time frame: 30 days after cesarean delivery

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

Local Subcutaneous Administration of Gentamicin for the Prevention of Surgical Site Infection Following Elective Cesarean Section: A Randomized Controlled Pilot Study.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 31, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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