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Prophylactic Antibiotics in Groin Hernioplasty

Prophylactic Antibiotics in Groin Hernioplasty: A Prospective Cohort Study on the Prevention of Surgical Site Infection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07111702
Enrollment
100
Registered
2025-08-08
Start date
2023-10-01
Completion date
2024-05-30
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Groin Hernia, Hernioplasty, Surgical Site Infection

Keywords

Antibiotic Prophylaxis, Wound Infection, Risk Factors

Brief 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 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.

Interventions

DRUGCefazolin

A single 2g intravenous dose administered once before surgery.

Sponsors

Al-Gumhori Teaching Hospital
CollaboratorUNKNOWN
Sana'a University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
17 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients (aged 17-80 years) undergoing primary open groin hernioplasty. * Provided written informed consent.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Surgical Site Infection (SSI)Within 30 days post-surgeryThe 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).

Secondary

MeasureTime frameDescription
Independent Risk Factors for Surgical Site Infection (SSI)From baseline through 30 days post-surgeryIdentification 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.

Countries

Yemen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026