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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Infection; Antibiotic Prophylaxis; Groin Hernia
• Intervention / Treatment: Drug: Cefazolin 1000 MG

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mohammad H Nabhan, M.D; Phone Number: +963956768862; Email: m.hassannabhan@gmail.com

Study Locations

• Syrian Arab Republic
  • Aleppo, Syrian Arab Republic
    • Recruiting
    • Aleppo University Hospital
    • Contact: Ahmad Y Arnaout, M.D; Phone Number: +963967306577; Email: yamen.arnout@gmail.com
    • Principal Investigator: Mohammad H Nabhan, M.D
    • Principal Investigator: Adel Bsata, PhD
    • Principal Investigator: Ahmad Al-Haj, PhD
    • Principal Investigator: Kusay Ayoub, PhD
    • Principal Investigator: Ammar Niazi, PhD
    • Principal Investigator: Ahmad Ghazal, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prophylaxis antibiotics Group; Patients with Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients.	Drug: Cefazolin 1000 MG; Medication: Cefazolin; Dosage: 1 gram; Administration Timing: A single dose will be administered preoperatively.
No Intervention: Non-antibiotics Group; Patients without Antibiotic Prophylaxis post-open Repair of Primary Elective Groin Hernias in High-Risk Patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Complication Rate	Overall complication rate; graded by the Clavien- Dindo complications classification system	up to 30 days after the surgery.
Wound infection/ Surgical site infection	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).	up to 30 days after the surgery.

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other Adverse events	Any adverse events will be observed during the follow-up period.	up to 30 days after the surgery.

Collaborators and Investigators

• Sponsor: University of Aleppo
• Collaborators: Aleppo University Hospital Resident Team

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative complications; Wound infection; Surgical site infection; Groin hernia; High-risk patients
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Hernia, Abdominal; Infections; Communicable Diseases; Hernia; Hernia, Inguinal; Wounds and Injuries; Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: AP-GH-OE-2023-HR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No