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Recruiting NCT06576154

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

Phase III Interventional Antibiotic Prophylaxis Wound Infection Groin Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cefazolin 1000 MG.
Who it may be relevant to
Registry conditions: Antibiotic Prophylaxis, Wound Infection, Groin Hernia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Syria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug Cefazolin 1000 MG
    * Medication: Cefazolin * Dosage: 1 gram * Administration Timing: A single dose will be administered preoperatively.

Primary outcome measures

  • Overall Complication Rate [Time frame: up to 30 days after the surgery.]
  • Wound infection/ Surgical site infection [Time frame: up to 30 days after the surgery.]
Secondary outcome measures (2)
  • Mortality Rate [Time frame: up to 30 days after the surgery.]
  • Hospital stay [Time frame: up to 30 days after the surgery.]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Syria · 1 center
  • Aleppo University Hospital — Aleppo

Identifiers

NCT: NCT06576154 · AP-GH-OE-2023-HR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗