Comparison of ampicillin/sulbactam versus clindamycin in the prevention of infection in patients undergoing head and neck surgery

Background. Patients requiring major oncologic head and neck surgery are at high risk for postoperative wound infection when the surgical site is contaminated by secretions from the upper aerodigestive tract. Studies to identify agents active in the prevention of postoperative wound infection may serve to reduce patient morbidity. Methods. Patients scheduled for a major contaminated head and neck surgical procedure were randomly assigned to receive either ampicillin/sulbactam or clindamycin. Medication was administered 1 to 2 hours prior to surgery and every 6 hours, for a total of five doses. Postoperatively, patients were followed daily for the development of wound infection or other septic complication. Results. A total of 242 patients were enrolled in the study; 119 received ampicillin/sulbactam, and 123 received clindamycin. A total of 169 patients were considered evaluable. Of the evaluable patients, 14% in each group developed a postoperative wound infection. There were no statistically significant differences between the number of days to onset of wound infection, nor was there a statistically significant difference in the rate of non-wound infections in the two groups. There were no statistically significant differences between the intent to treat group and the evaluable group of patients. Conclusion. It is concluded that ampicillin/sulbactam is as safe and effective as clindamycin in preventing postoperative wound infection following major head and neck surgery. (C) 1997 John Wiley & Sons, Inc.