Prophylactic Antibiotics in Groin Hernioplasty

NCT07111702 | Completed

• 1 other identifier: SU-Hernia-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection; Groin Hernia; Hernioplasty

Keywords

Antibiotic Prophylaxis; Wound Infection; Risk Factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Independent Risk Factors for Surgical Site Infection (SSI)

  From baseline through 30 days post-surgery

Study Arms (2)

Antibiotic Group

EXPERIMENTAL

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

Drug: Cefazolin

No Antibiotic Group

NO INTERVENTION

Patients did not receive antibiotic prophylaxis.

Interventions

Cefazolin DRUG

A single 2g intravenous dose administered once before surgery.

Antibiotic Group

Eligibility Criteria

• Age: 17 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sana'a University: lead
• Al-Gumhori Teaching Hospital: collaborator

Study Sites (1)

Al-Gumhori Teaching Hospital

Sanaa, Yemen

Location

MeSH Terms

Conditions

Surgical Wound Infection; Hernia, Inguinal; Wound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Waleed Mohammed Gilan, Asssociate Professor

  Faculty of Medicine and Health Sciences, Sana'a University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: October 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

YE (1)