An interventional study of Cefazolin in Surgical Site Infection, Groin Hernia and Hernioplasty, sponsored by Sana'a University. Completed at 1 site in Yemen. Open to male participants aged 17 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Sana'a University · Not applicable, Interventional, and Prevention
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.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's enrollment of 100 is below the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Sana'a University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received a single intravenous dose of cefazolin (2 g) 30-60 min prior to skin incision.
Drug: Cefazolin
Patients did not receive antibiotic prophylaxis.
A single 2g intravenous dose administered once before surgery.
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).
Time frame: Within 30 days post-surgery
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.
Time frame: From baseline through 30 days post-surgery
Plan to share: 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.
Time frame: Data will be available beginning 3 months after article publication and the access period will remain open for 5 years.
Access criteria: Data will be made available to qualified researchers for meta-analysis or other secondary analyses. Researchers must submit a methodologically sound proposal to the corresponding author at h.jowah@su.edu.ye. A signed data access agreement will be required.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cefazolin
Sana'a University