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RecruitingNCT07311395Updated Jun 26, 2026

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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
02

Conditions studied

  • Surgical Site Infection
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Local subcutaneous gentamicin

    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

  • Placebo comparator
    Local subcutaneous placebo (saline)

    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

  • DrugGentamicin

    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.

  • DrugStandard antibiotic prophylaxis

    Participants receive standard systemic antibiotic prophylaxis according to institutional protocol.

  • OtherPlacebo (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.

05

What researchers measure

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.

    Time frame: within 30 days after cesarean section

Secondary outcomes

  1. Surgical site infection within 30 days after cesarean delivery

    Time frame: 30 days after cesarean delivery

06

Study locations

1 of 1 sites recruiting
  • Western Galilee Hospital-Nahariya
    Nahariya, Israel
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07311395
Lead sponsor
Western Galilee Hospital-Nahariya
Responsible party
Dr. Nadir Ganem (Principal Investigator, Western Galilee Hospital-Nahariya) — Principal investigator
First posted
Dec 31, 2025
Start date
Dec 8, 2025
Primary completion
Jan 7, 2027 (estimated)
Completion
Jan 7, 2027 (estimated)
Last update
Jun 26, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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