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

NCT07311395 | Recruiting

• 1 other identifier: 0177-25-NHR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  within 30 days after cesarean section

Secondary Outcomes (1)

• Surgical site infection within 30 days after cesarean delivery

  30 days after cesarean delivery

Study Arms (2)

Local subcutaneous gentamicin

EXPERIMENTAL

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

Local subcutaneous placebo (saline)

PLACEBO COMPARATOR

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)

Interventions

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.

Local subcutaneous gentamicin

Standard antibiotic prophylaxis DRUG

Participants receive standard systemic antibiotic prophylaxis according to institutional protocol.

Local subcutaneous gentamicin; Local subcutaneous placebo (saline)

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.

Local subcutaneous placebo (saline)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is limited to individuals of the female biological sex due to the nature of elective cesarean delivery.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Western Galilee Hospital-Nahariya

Nahariya, Israel

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Gentamicins; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 31, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): January 7, 2027
• Study Completion (Estimated): January 7, 2027
• Last Updated: June 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)