Prophylactic Antibiotics in Groin Hernioplasty

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection; Groin Hernia; Hernioplasty
• Intervention / Treatment: Drug: Cefazolin

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Yemen
  • Sana'a, Yemen
    • Al-Gumhori Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antibiotic Group; Patients received a single intravenous dose of cefazolin (2 g) 30-60 min prior to skin incision.	Drug: Cefazolin; A single 2g intravenous dose administered once before surgery.
No Intervention: No Antibiotic Group; Patients did not receive antibiotic prophylaxis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Within 30 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline through 30 days post-surgery

Collaborators and Investigators

• Sponsor: Sana'a University
• Collaborators: Al-Gumhori Teaching Hospital
• Investigators: Principal Investigator: Waleed Mohammed Gilan, Asssociate Professor, Faculty of Medicine and Health Sciences, Sana'a University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: August 1, 2025
• First Submitted That Met QC Criteria: August 1, 2025
• First Posted (Actual): August 8, 2025

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Risk Factors; Antibiotic Prophylaxis; Wound Infection
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Wound Infection; Infections; Surgical Wound Infection; Anti-Bacterial Agents; Anti-Infective Agents; Cefazolin
• Other Study ID Numbers: SU-Hernia-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available beginning 3 months after article publication and the access period will remain open for 5 years.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No