Prophylactic Antibiotics in Groin Hernioplasty

Sana'a University

Status: Completed

Conditions: Surgical Site Infection; Hernioplasty; Groin Hernia

Treatments: Drug: Cefazolin

Study type: Interventional

Funder types: Other

Identifiers

NCT07111702

SU-Hernia-001

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Male

Ages: 17 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Antibiotic Group

Experimental group

Description:

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

Treatment:

Drug: Cefazolin

No Antibiotic Group

No Intervention group

Description:

Patients did not receive antibiotic prophylaxis.