NCT07311395

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2026

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

December 15, 2025

Last Update Submit

December 15, 2025

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • postoperative surgical site infection

    within 30 days after cesarean section

Study Arms (2)

Local subcutaneous gentamicin

EXPERIMENTAL
Drug: Gentamicin

Standard antibiotc prophylaxis

ACTIVE COMPARATOR
Drug: Standard antibiotic prophylaxis

Interventions

GentamicinDRUG

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 prophylaxisDRUG

Participants receive standard systemic antibiotic prophylaxis according to institutional protocol.

Standard antibiotc prophylaxis

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is limited to individuals of the female biological sex due to the nature of elective cesarean delivery.
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Galilee Hospital-Nahariya

Nahariya, Israel

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

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

January 7, 2026

Study Completion

January 7, 2026

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)