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OpenTrials
Completed

NCT Number: NCT07111702

Prophylactic Antibiotics in Groin Hernioplasty

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.

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Key information

Conditions

Surgical Site Infection Groin Hernia Hernia Hernia, Abdominal Hernia, Inguinal Hernioplasty Infections Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

17 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Al-Gumhori Teaching Hospital

Sanaa, Yemen

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cefazolin

Drug

A single 2g intravenous dose administered once before surgery.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Independent Risk Factors for Surgical Site Infection (SSI)

    Time frame: From baseline through 30 days post-surgery

    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.

Sponsors and collaborators

Lead sponsor

Sana'a University

Other

Collaborators

  • Al-Gumhori Teaching Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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