Surgical Site InfectionNCT07111702
Prophylactic Antibiotics in Groin Hernioplasty
A study testing Cefazolin in people with Surgical Site Infection and Groin Hernia, run by Sana'a University at 1 site in Yemen.
Trial summary
The role of prophylactic antibiotics in preventing surgical site infections (SSI) for clean procedures like groin hernia repair remains controversial. This study aimed to evaluate the association between antibiotic prophylaxis and SSI rates in a real-world clinical setting and to identify independent risk factors for… Read more about this study
- Who is it for?
- Ages 17 to 80 years, men only
- Conditions the study is for
- Surgical Site Infection, Groin Hernia, Hernioplasty
- What is being tested?
- Cefazolin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteYemen
- Study dates
- 1 Oct 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients (aged 17-80 years) undergoing primary open groin hernioplasty.
- Provided written informed consent.
Who cannot join
- Recurrent, emergency, or complicated (e.g., incarcerated, strangulated) hernias.
- Laparoscopic repairs.
- Known immunosuppression, ongoing antibiotic therapy, or a known allergy to cefazolin.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Antibiotics in Groin Hernioplasty: A Prospective Cohort Study on the Prevention of Surgical Site Infection
The role of prophylactic antibiotics in preventing surgical site infections (SSI) for clean procedures like groin hernia repair remains controversial. This study aimed to evaluate the association between antibiotic prophylaxis and SSI rates in a real-world clinical setting and to identify independent risk factors for SSI. The study prospectively followed 100 male patients undergoing elective open groin hernioplasty. Patients were categorized based on the surgeon's decision into two groups: those who received a single dose of intravenous cefazolin (Antibiotic Group) and those who did not (No Antibiotic Group). The main outcome was the rate of SSI within 30 days of surgery.
- Conditions
- Surgical Site Infection, Groin Hernia, Hernioplasty
- Being tested
- Cefazolin
- Keywords
- Antibiotic Prophylaxis, Wound Infection, Risk Factors
- Medical subject headings
- Surgical Wound Infection, Hernia, Inguinal, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
A single 2g intravenous dose administered once before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic Group | Experimental | Patients received a single intravenous dose of cefazolin (2 g) 30-60 min prior to skin incision. Receives: Drug: Cefazolin |
| No Antibiotic Group | No intervention | Patients did not receive antibiotic prophylaxis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Infection (SSI)
The rate of surgical site infection diagnosed within 30 days of surgery, based on Centers for Disease Control and Prevention (CDC) clinical criteria (e.g., purulent discharge, erythema, localized pain or swelling).
Measured: Within 30 days post-surgery
Secondary outcomes (1)
Independent Risk Factors for Surgical Site Infection (SSI)
Identification of baseline and operative variables independently associated with the development of SSI. This was assessed using a multivariable logistic regression model to calculate adjusted odds ratios for factors such as high Body Mass Index (BMI), prolonged operative time, and high American Society of Anesthesiologists (ASA) score.
Measured: From baseline through 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Oct 2023
- Primary completion30 May 2024
- Study completion30 May 2024
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Gumhori Teaching Hospital
- Responsible party
- Principal investigator, Haitham Mohammed Jowah, Sana'a University
- Investigators
- Waleed Mohammed Gilan, Asssociate Professor, Principal investigator, Faculty of Medicine and Health Sciences, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111702
- Sponsor's protocol ID
- SU-Hernia-001
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article will be made available after publication. This includes data on baseline characteristics, group allocation, and the primary outcome.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotics in Groin Hernioplasty: A Prospective Cohort Study on the Prevention of Surgical Site Infection
- ClinicalTrials.gov ID
- NCT07111702
- Acronym / sponsor ID
- SU-Hernia-001
- Conditions
- Surgical Site Infection, Groin Hernia, Hernioplasty
- Keywords
- Antibiotic Prophylaxis, Wound Infection, Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Collaborators
- Al-Gumhori Teaching Hospital
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 8 Aug 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 role of prophylactic antibiotics in preventing surgical site infections (SSI) for clean procedures like groin hernia repair remains controversial. This study aimed to evaluate the association between antibiotic prophylaxis and SSI rates in a real-world clinical setting and to identify independent risk factors for SSI. The study prospectively followed 100 male patients undergoing elective open groin hernioplasty. Patients were categorized based on the surgeon's decision into two groups: those who received a single dose of intravenous cefazolin (Antibiotic Group) and those who did not (No Antibiotic Group). The main outcome was the rate of SSI within 30 days of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic Group | Experimental | Drug: CefazolinPatients received a single intravenous dose of cefazolin (2 g) 30-60 min prior to skin incision. |
| No Antibiotic Group | No intervention | –Patients did not receive antibiotic prophylaxis. |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (aged 17-80 years) undergoing primary open groin hernioplasty.
- Provided written informed consent.
Key exclusion criteria (4 listed)
- Recurrent, emergency, or complicated (e.g., incarcerated, strangulated) hernias.
- Laparoscopic repairs.
- Known immunosuppression, ongoing antibiotic therapy, or a known allergy to cefazolin.
- Refusal to participate.
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 |
|---|---|---|
| CefazolinA single 2g intravenous dose administered once before surgery. | Drug | Antibiotic Group |
Primary outcome
Incidence of Surgical Site Infection (SSI)
Time frame: Within 30 days post-surgery
The rate of surgical site infection diagnosed within 30 days of surgery, based on Centers for Disease Control and Prevention (CDC) clinical criteria (e.g., purulent discharge, erythema, localized pain or swelling).
1 secondary outcome
Independent Risk Factors for Surgical Site Infection (SSI)
Time frame: From baseline through 30 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article will be made available after publication. This includes data on baseline characteristics, group allocation, and the primary outcome.
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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. This study is not recruiting at the moment.
Waleed Mohammed Gilan, Asssociate Professor principal investigator
Faculty of Medicine and Health Sciences, Sana'a University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefazolin in people with Surgical Site Infection and Groin Hernia, run by Sana'a University at 1 site in Yemen.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 13 Aug 2025. 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 Yemen. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Surgical Site Infection (SSI) (time frame: Within 30 days post-surgery). 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 13 Aug 2025.