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NCT Number: NCT06576154

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

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.

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Key information

Conditions

Antibiotic Prophylaxis Groin Hernia Hernia Hernia, Abdominal Hernia, Inguinal Infections Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aleppo University Hospital

Aleppo, Syria

Location status: Recruiting

Location contact

Adel Bsata, PhD

PRINCIPAL_INVESTIGATOR

Ahmad Al-Haj, PhD

PRINCIPAL_INVESTIGATOR

Ahmad Ghazal, PhD

PRINCIPAL_INVESTIGATOR

Ahmad Y Arnaout, M.D

CONTACT

[email protected]

+963967306577

Ammar Niazi, PhD

PRINCIPAL_INVESTIGATOR

Kusay Ayoub, PhD

PRINCIPAL_INVESTIGATOR

Mohammad H Nabhan, M.D

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CeFAZolin 1000 MG

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

Primary outcomes

  1. Overall Complication Rate

    Time frame: up to 30 days after the surgery.

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

  2. 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

  1. Mortality Rate

    Time frame: up to 30 days after the surgery.

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

  2. Hospital stay

    Time frame: up to 30 days after the surgery.

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

Other outcomes

  1. Other Adverse events

    Time frame: up to 30 days after the surgery.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad H Nabhan, M.D

CONTACT

[email protected]

+963956768862

Sponsors and collaborators

Lead sponsor

University of Aleppo

Other

Collaborators

  • Aleppo University Hospital Resident Team

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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