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

NCT06576154 | Recruiting Phase 3 DMC

• 1 other identifier: AP-GH-OE-2023-HR
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic Prophylaxis; Wound Infection; Groin Hernia

Keywords

Groin hernia; Postoperative complications; Wound infection; Surgical site infection; High-risk patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Mortality Rate

  up to 30 days after the surgery.

• Hospital stay

  up to 30 days after the surgery.

Other Outcomes (1)

• Other Adverse events

  up to 30 days after the surgery.

Study Arms (2)

Prophylaxis antibiotics Group

EXPERIMENTAL

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

Drug: Cefazolin 1000 MG

Non-antibiotics Group

NO INTERVENTION

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

Interventions

Cefazolin 1000 MG DRUG

* Medication: Cefazolin * Dosage: 1 gram * Administration Timing: A single dose will be administered preoperatively.

Prophylaxis antibiotics Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Aleppo: lead
• Aleppo University Hospital Resident Team: collaborator

Study Sites (1)

Aleppo University Hospital

Aleppo, Syria

RECRUITING

MeSH Terms

Conditions

Wound Infection; Hernia, Inguinal; Postoperative Complications; Surgical Wound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Infections; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Mohammad H Nabhan, M.D

CONTACT

+963956768862; m.hassannabhan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 28, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)