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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.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06576154
Enrollment
200
Registered
2024-08-28
Start date
2024-08-01
Completion date
2025-09-01
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Prophylaxis, Wound Infection, Groin Hernia

Keywords

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

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.

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

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

Sponsors

Aleppo University Hospital Resident Team
CollaboratorUNKNOWN
University of Aleppo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall Complication Rateup to 30 days after the surgery.Overall complication rate; graded by the Clavien- Dindo complications classification system
Wound infection/ Surgical site infectionup 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

MeasureTime frameDescription
Mortality Rateup to 30 days after the surgery.The measure of the number of deaths at the end of the study.
Hospital stayup to 30 days after the surgery.In days: Number of days, patient in hospital since admission.

Other

MeasureTime frameDescription
Other Adverse eventsup to 30 days after the surgery.Any adverse events will be observed during the follow-up period.

Countries

Syria

Contacts

Primary ContactMohammad H Nabhan, M.D
m.hassannabhan@gmail.com+963956768862

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026