Using antibiotics to prevent infections after jaw surgery
The Use of Single Dose vs Short-Term Peri-Operative Cefazolin in the Prevention of Surgical Site Infection Following Orthognathic Surgery
This study tests whether giving antibiotics before and after jaw surgery can help prevent infections in patients who are having surgery to fix jaw and facial problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT05852158 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of peri-operative antibiotics in reducing the incidence of surgical site infections (SSIs) following orthognathic surgery, which aims to correct jaw and facial deformities. The study will involve administering Cefazolin injections to patients undergoing these procedures, focusing on optimizing antibiotic protocols to minimize infection rates. Participants will be monitored for SSI occurrences post-surgery to evaluate the impact of the antibiotic regimen. The trial aims to establish a more effective approach to antibiotic use in this surgical context.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 16 and older with ASA physical status classifications 1 and 2 who are scheduled for orthognathic surgery.
Not a fit: Patients with ASA classifications 3 and higher, recent antibiotic use, or those with systemic infections or immunosuppression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the rate of infections following orthognathic surgery, leading to better patient outcomes and reduced healthcare costs.
How similar studies have performed: Previous studies have shown that peri-operative antibiotics can reduce SSI rates in similar surgical contexts, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients ASA 1 and 2 over the age of 16 undergoing orthognathic surgery will be offered participation in this study Exclusion Criteria: * Patients ASA 3 and higher, use of antibiotics in the preceding 2 weeks, presence of systemic, oral, or odontogenic infections, patients in a state of immunosuppression as a result of medications or systemic disease, patients with allergies to penicillins or cephalosporins, and patients who lack capacity for informed consent.
Where this trial is running
Halifax, Nova Scotia
- Victoria General Hospital — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Study coordinator: Abdul El-Rabbany, DMD, BSc
- Email: abdul.elrabbany@dal.ca
- Phone: 1-902-473-2070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.