Prophylactic Antibiotics in Groin Hernioplasty

Not Applicable

Completed

• Conditions: Surgical Site Infection; Groin Hernia; Hernioplasty
• Interventions: Drug: Cefazolin

• Registration Number: NCT07111702
• Lead Sponsor: Sana'a University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30
• Status Verified: 2025-08
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic Group	Cefazolin	Patients received a single intravenous dose of cefazolin (2 g) 30-60 min prior to skin incision.

Primary Outcome Measures

Name	Time	Method
Incidence of Surgical Site Infection (SSI)	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 Outcome Measures

Name	Time	Method
Independent Risk Factors for Surgical Site Infection (SSI)	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.

Trial Locations

Locations (1)

Al-Gumhori Teaching Hospital; 🇾🇪 Sana'a, Yemen