Orthognathic Surgery and Postoperative Antibiotic Use: 1-Day Vs. 3-Day Prospective Trial

Surgical site infection (SSI) is the most frequent complication seen following orthognathic surgery.¹ The present study attempts to identify if there is benefit to an extended regimen of antibiotics in preventing SSI in orthognathic patients. A prospective, randomized, double blind controlled trial comparing 3 doses of IV Kefzol or Clindamycin, with 3 doses of IV Kefzol or Clindamycin followed by an additional 2 days oral Keflex or Clindamycin, is currently underway.

Ethics board approval CDHA-RS/2013-297 was obtained and all particpants provided written informed consent. All patients received 1 day (3 doses) of IV antibiotics. Patients enrolled in this study were instructed to pick up a prescription from the hospital pharmacy. This was for either a placebo elixer or antibiotic elixir which was taken for an 2 additional days (8 doses) following the 3 IV doses. Intra-operatively all surgical sites were prepared with 10% betadine and all patients received 0.12% chlorhexidine rinse for 2 weeks post operatively. Diagnosis of infection was based on CDC criteria for SSI: purulent drainage, wound culture for known pathogen, at least one sign and symptom of infection (pain, tenderness, localized swelling, redness or heat). Patients were seen for follow-up in clinic for 1-2 months after surgery, and called 1 year after surgery to assess for any missed SSI that may have occurred. Primary outcome was development of SSI. Medical comorbidities were documented.

A midpoint evaluation of the first 150 patients enrolled between July 2013 and July 2014 was completed. Of the 150 patients, 7 withdrew prior to surgery or their surgery was cancelled. Fifty-two patients either did not pick up their study medication, did not take medication as directed or withdrew themselves prior to completing the 8 doses. Ninety-one patients completed the study, 83 received kefzol/Keflex, and 8 received clindamycin. In the Kefzol/Kelfex group(n= 39), two patients (5%) developed SSI. Fourty-four (53%) patients received the placebo and 9 (20%) developed SSI. This was statistically significant p<0.04. In the placebo group one patient had an autoimmune disease and had received immunosuppression therapy. Two patients were smokers. Eight patients were randomized to receive Clindamycin, 4 received oral clindamycin, and 4 received placebo. One SSI was seen in the group that received clindamycin. Ten SSI occurred in the mandible, and one in the left maxilla. The time of diagnosis of SSI ranged from 12 days to 157 days, with a mean 44.6 days.

To date, this is the largest prospective trial investigating postoperative antibiotic use following orthognathic surgery. We found a significant difference in rate of infection between the antibiotic and placebo groups. This is consistent with Chow et. al and Danda et al. who found that 2-3 days of post-operative antibiotics reduced SSI significantly^1,2. They also found there was significantly more infections occuring in the mandible^1,2. This may be due to decreased vascularity and pooling of saliva.² In conclusion, our prospective trial demonstrates a significant decrease in the rate of SSI by extending oral antibiotic coverage for 3 days following orthognathic surgery. Antimicrobial coverage beyond 3 days may add further reduction in SSI but this has not been investigated in our current study.

References:

1. Chow LK, Singh B, et al. Prevalence of Postoperative Complications After Orthognathic Surgery: A 15year Review. J Oral Maxillofacial Surgery 65:984-992, 2007
2. Danda AK, Ravi P. Effectiveness of Postoperative Antibiotics in Orthognathic Surgery: A Meta-Analysis. J Oral Maxillofacial Surgery 69:2650-2656,2011