The Role of Antibiotic Prophylaxis in Lowering Wound Infection Rates Post-Open Repair of Primary Elective Groin Hernias in High-Risk Patients: A Randomized Control Trial.
Overview
- Phase
- Phase 3
- Intervention
- Cefazolin 1000 MG
- Conditions
- Antibiotic Prophylaxis
- Sponsor
- University of Aleppo
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Overall Complication Rate
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Ahmad Yamen Arnaout
Principal Investigator
University of Aleppo
Eligibility Criteria
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
- •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.
Arms & Interventions
Prophylaxis antibiotics Group
Patients with Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients.
Intervention: Cefazolin 1000 MG
Outcomes
Primary Outcomes
Overall Complication Rate
Time Frame: up to 30 days after the surgery.
Overall complication rate; graded by the Clavien- Dindo complications classification system
Wound infection/ Surgical site infection
Time Frame: 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 Outcomes
- Hospital stay(up to 30 days after the surgery.)
- Mortality Rate(up to 30 days after the surgery.)