Antibiotic prophylaxis in clean head and neck surgery: A prospective randomised controlled trial

Objective: Antibiotic prophylaxis is not indicated for clean head and neck surgery. However, its role in revision cases is not known. The objective was to prospectively test whether antibiotics are useful in this patient group. Design: This was a prospective, double-blind, randomised, placebo-controlled study. Setting: A single-centre study in a tertiary care centre. Participants: The patients were selected from a referred sample of adult patients (>18 years old) who were planned to undergo revision clean head and neck surgery and who had no preoperative indication for prophylactic antibiotics (eg previous radiation therapy, tracheostomy, active infection, immunosuppression). A total of 59 patients were approached for the study. After exclusion, 53 were available for final analysis. Intervention: The intervention group received a single-dose cefazolin, while the control group received placebo. Main outcomes: The primary end-point was the combined rate of surgical wound infection, bacteremia and sepsis. The secondary end-points were length of hospital stay and drug-induced adverse reactions. Results: A total of 53 patients were randomised to 2 groups: 31 to antibiotics group and 22 to control group. There was no difference between the groups in baseline characteristics. The primary end-point occurred in both groups at the same rate. There was no difference in secondary end-point rate, as well. Conclusion: Prophylactic antibiotics appear to have no benefit in revision, clean head and neck surgery. Further studies in larger populations and other settings are needed. (ClinicalTrials.gov number NCT01980082, clinicaltrials.gov/ct2/show/NCT01980082).