Prophylactic vs postoperative antibiotic use in complex septorhinoplasty surgery: a prospective, randomized, single-blind trial comparing efficacy.

OBJECTIVE To compare the efficacy of prophylactic vs postoperative antibiotic use in complex septorhinoplasty and strengthen the evidence base for antibiotic use in nasal surgery. DESIGN A randomized, prospective, single-blinded trial. One hundred sixty-four patients requiring complex septorhinoplasty surgery were recruited sequentially from the waiting lists of the 2 senior authors. Power was calculated at 80% at the 5% significance level. Patients randomized to the prophylactic arm of the study received three 1200-mg intravenous doses of amoxicillin-clavulanate, given at induction of anesthesia and at 6 and 12 hours postoperatively. Patients in the postoperative antibiotic arm received a 7-day course of 375 mg of amoxicillin-clavulanate 3 times a day. Patients allergic to penicillin were given erythromycin. Clinical and microbiological evidence of infection on the 10th postoperative day was categorized as either minor (vestibulitis) or major (nasal or septal cellulitis, septal abscess, secondary hemorrhage, or donor-site infection) infections. RESULTS At follow-up, 6 (7%) of 82 patients in the prophylactic arm and 9 (11%) of 82 of patients in the postoperative arm showed evidence of infection. Most (80%) of infections were minor. There was no significant difference in infection rates between the prophylactic and postoperative arms on chi2 analysis (P = .42). All 164 patients completed the study on an intention-to-treat basis. CONCLUSION We recommend the use of prophylactic antibiotics rather than empirical postoperative antibiotics for patients undergoing complex septorhinoplasty.