Actively Recruiting

Phase 4
Age: 16Years +
All Genders
ID05852158

The Use of Single Dose vs Short-Term Peri-Operative Cefazolin in the Prevention of Surgical Site Infection Following Orthognathic 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery and 24 hours post-operatively

Participants undergo orthognathic surgery and receive either a single pre-operative dose of 2g IV cefazolin or a single pre-operative dose plus a 24-hour course of cefazolin post-operatively.

Surgery day plus post-operative monitoring during hospital stay

Post-operative Follow-up

Duration - 6 weeks following surgery

Participants return for follow-up visits to monitor for surgical site infections and adverse effects related to antibiotic treatment.

3 visits (at 2 weeks, 4 weeks, and 6 weeks post-surgery)

Trial Site Locations

Total: 1 location

1

Victoria General Hospital

Halifax, Nova Scotia, Canada, B3H2Y9

Actively Recruiting

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Research Team

A

Abdul El-Rabbany, DMD, BSc

C

Curtis Gregoire, MD, DDS, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Preoperative antibiotic prophylaxis in orthognathic surgery: a randomized, double-blind, and placebo-controlled clinical study.

S A Zijderveld, L E Smeele, P J Kostense...

https://pubmed.ncbi.nlm.nih.gov/10596659

Prevalence of Surgical Site Infections Following Orthognathic Surgery: A Double-Blind, Randomized Controlled Trial on a 3-Day Versus 1-Day Postoperative Antibiotic Regimen.

Clayton M Davis, Curtis E Gregoire, Ian Davis...

https://pubmed.ncbi.nlm.nih.gov/27789268