Surgical Site InfectionNCT07311395
Local Subcutaneous Gentamicin for Prevention of Surgical Site Infection After Elective Cesarean Section
A study testing Gentamicin and Standard antibiotic prophylaxis in people with Surgical Site Infection, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Gentamicin and Standard antibiotic prophylaxis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Dec 2025to 7 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Western Galilee Hospital-Nahariya
Nahariya
Principal Investigator, +972-50-2061077, NadirG@gmc.gov.il
About this study
Official title: Local Subcutaneous Administration of Gentamicin for the Prevention of Surgical Site Infection Following Elective Cesarean Section: A Randomized Controlled Pilot Study.
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?
Read more
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
- Being tested
- Gentamicin, Standard antibiotic prophylaxis, Placebo (saline)
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard antibiotic prophylaxisDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard antibiotic prophylaxis; Other: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days after cesarean section
Secondary outcomes (1)
Surgical site infection within 30 days after cesarean delivery
Measured: 30 days after cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start8 Dec 2025
- Primary completion7 Jan 2027 (estimated)
- Study completion7 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Nadir Ganem, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311395
- Sponsor's protocol ID
- 0177-25-NHR
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Subcutaneous Administration of Gentamicin for the Prevention of Surgical Site Infection Following Elective Cesarean Section: A Randomized Controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT07311395
- Acronym / sponsor ID
- 0177-25-NHR
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 7 Jan 2027 (estimated)
- Study completion
- 7 Jan 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local subcutaneous gentamicin | Experimental | Drug: Gentamicin, Drug: Standard antibiotic prophylaxisParticipants 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. |
| Local subcutaneous placebo (saline) | Placebo comparator | Drug: Standard antibiotic prophylaxis, Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GentamicinParticipants 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. | Drug | Local subcutaneous gentamicin |
| Standard antibiotic prophylaxisParticipants receive standard systemic antibiotic prophylaxis according to institutional protocol. | Drug | Local subcutaneous gentamicin, Local subcutaneous placebo (saline) |
| Placebo (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. | Other | Local subcutaneous placebo (saline) |
Primary outcome
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.
1 secondary outcome
Surgical site infection within 30 days after cesarean delivery
Time frame: 30 days after cesarean delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentamicin and Standard antibiotic prophylaxis in people with Surgical Site Infection, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite wound complication within 30 days after cesarean delivery (time frame: within 30 days after cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.