The Role of Antibiotic Prophylaxis in Lowering Wound Infection Rates Post-Open Repair of Primary Elective Groin Hernias in High-Risk Patients

Phase 3

Recruiting

• Conditions: Antibiotic Prophylaxis; Wound Infection; Groin Hernia
• Interventions: Drug: Cefazolin 1000 MG

• Registration Number: NCT06576154
• Lead Sponsor: University of Aleppo

Brief Summary

This study aims to investigate the impact of antibiotic prophylaxis on reducing wound infection rates following open repair of primary elective groin hernias in high-risk patients.

Detailed Description

This study will be a randomized controlled trial involving high-risk patients undergoing open repair of primary elective groin hernias. Participants will be randomized into two groups: one receiving antibiotic prophylaxis and the other serving as the control group. The study will assess the incidence of wound infections postoperatively in both groups to determine the effectiveness of antibiotic prophylaxis in lowering infection rates.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Volunteer to participate in the study.
• Elderly patients aged over 60 years.
• Patients with Diabetes.
• Or obese patients with a BMI greater than 35.
• Or immunocompromised patients.
• Or American Society of Anesthesiologists (ASA) physical status classification 2 or more, with a history of more than 10 years.

Exclusion Criteria

• Non-cooperative patients for regular follow-up.
• Therapeutic Indication for.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylaxis antibiotics Group	Cefazolin 1000 MG	Patients with Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients.

Primary Outcome Measures

Name	Time	Method
Overall Complication Rate	up to 30 days after the surgery.	Overall complication rate; graded by the Clavien- Dindo complications classification system
Wound infection/ Surgical site infection	up to 30 days after the surgery.	has been defined and classified as superficial incisional, deep incisional, and organ/ space_ surgical site infection by the Centers for Disease Control and Prevention (CDC) (Anderson 2014; Ban 2017; Berríos-Torres 2017).

Secondary Outcome Measures

Name	Time	Method
Hospital stay	up to 30 days after the surgery.	In days: Number of days, patient in hospital since admission.
Mortality Rate	up to 30 days after the surgery.	The measure of the number of deaths at the end of the study.

Trial Locations

Locations (1)

Aleppo University Hospital; 🇸🇾 Aleppo, Syrian Arab Republic