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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aleppo

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Volunteer to participate in the study.

Elderly patients aged over 60 years.

Patients with Diabetes.

Or obese patients with a BMI greater than 35.

Disqualifiers

Non-cooperative patients for regular follow-up.

Therapeutic Indication for.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cefazolin 1000 MG

    Drug

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Prophylaxis antibiotics GroupExperimental treatment 1 intervention
Group B: Non-antibiotics GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Overall Complication Rate

Overall complication rate; graded by the Clavien- Dindo complications classification system

Time frame
up to 30 days after the surgery.
2

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).

Time frame
up to 30 days after the surgery.

Secondary outcomes

1

Mortality Rate

The measure of the number of deaths at the end of the study.

Time frame
up to 30 days after the surgery.
2

Hospital stay

In days: Number of days, patient in hospital since admission.

Time frame
up to 30 days after the surgery.

Other outcomes

1

Other Adverse events

Any adverse events will be observed during the follow-up period.

Time frame
up to 30 days after the surgery.

Sponsors and contacts

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University of Aleppo

Lead sponsor

Aleppo University Hospital Resident Team

Collaborator