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Actively Recruiting

Phase 4
Age: 16Years +
All Genders
ID05852158

Comparing Single Dose and 24-Hour Cefazolin Antibiotic Use to Prevent Infection After Jaw Surgery

Led by Abdul El-Rabbany · Updated on 2026-03-19

400

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Orthognathic surgery involves procedures to correct jaw and facial bone deformities, aiming to improve speech, jaw and dental function, appearance, and sleep apnea symptoms. This study evaluates the use of antibiotics to prevent infections after these surgeries, focusing on whether a single dose before surgery is as effective as a 24-hour course including post-operative doses. The research is motivated by concerns over antibiotic resistance and aims to find the best balance between infection prevention and minimizing antibiotic use. Participants are randomly assigned to one of two groups. Group A receives a single pre-operative dose of 2g intravenous cefazolin. Group B receives the same pre-operative dose plus three additional doses every 8 hours over 24 hours after surgery. Both groups follow the same surgical procedures and post-operative care, including use of a chlorhexidine mouth rinse for two weeks. Follow-ups occur at 2, 4, and 6 weeks post-surgery to monitor for surgical site infections and other complications. During the study, researchers collect information on patient age, sex, smoking status, surgical details, and any medication side effects. Surgical site infections are classified according to CDC criteria and recorded along with treatment details. Safety and adverse events are monitored continuously, and participants may withdraw at any time. Data will be stored securely and analyzed to determine if post-operative antibiotic doses provide additional benefits over a single pre-operative dose. Total participation lasts about 6 weeks after surgery with scheduled follow-up visits.

CONDITIONS

Brief Title

Antibiotics for Prevention of Infection Following Orthognathic Surgery

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 16 years or older
  • Patients classified as ASA 1 or 2
  • Patients scheduled to undergo orthognathic surgery
  • Patients able to provide informed consent
Not Eligible

You will not qualify if you...

  • Patients classified as ASA 3 or higher
  • Use of antibiotics within the preceding 2 weeks
  • Presence of systemic, oral, or odontogenic infections
  • Patients with immunosuppression due to medications or systemic disease
  • Allergies to penicillin or cephalosporin antibiotics
  • Patients lacking capacity for informed consent

Research Team

A

Abdul El-Rabbany, DMD, BSc

C

Curtis Gregoire, MD, DDS, MSc

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