Incidence of complications and problems related to orthognathic surgery: a review of 655 patients.
K Panula, K Finne, K Oikarinen
https://pubmed.ncbi.nlm.nih.gov/11573165Actively Recruiting
Led by Abdul El-Rabbany · Updated on 2026-03-19
400
Participants Needed
1
Research Sites
25 weeks
Total Duration
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
Antibiotics for Prevention of Infection Following Orthognathic Surgery
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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)
Total: 1 location
1
Victoria General Hospital
Halifax, Nova Scotia, Canada, B3H2Y9
Actively Recruiting
A
Abdul El-Rabbany, DMD, BSc
C
Curtis Gregoire, MD, DDS, MSc
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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