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

University of Aleppo

Status and phase: Enrolling; Phase 3

Conditions: Groin Hernia; Wound Infection; Antibiotic Prophylaxis

Treatments: Drug: Cefazolin 1000 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06576154

AP-GH-OE-2023-HR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Prophylaxis antibiotics Group

Experimental group

Description:

Patients with Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients.

Treatment:

Drug: Cefazolin 1000 MG

Non-antibiotics Group

No Intervention group

Description:

Patients without Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients.