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A Prospective, Randomized, Controlled Trial of Prophylactic Antibiotics

Soo-Kim Ong, MBChB; Randall P. Morton, MSc, MBBS, FRACS; John Kolbe, MBBS, FRACP; Ralph M. L. Whitlock, MBChB, FRACP, DIC; Nicholas P. McIvor, MBChB, FRCS, FRACS

Arch Otolaryngol Head Neck Surg. 2004;130:1084-1087.

Objective  To test the hypothesis that extended postoperative antibiotic cover would reduce the incidence of pulmonary complications in patients undergoing major head and neck surgery with tracheostomy.

Design  A prospective, randomized, controlled trial was carried out to determine the efficacy of an extended course (5 days) of intravenous amoxicillin–clavulanic acid in reducing the rate of atelectasis and pulmonary infections postoperatively. Other possible risk factors that might predispose to pulmonary complications were also evaluated.

Setting  Tertiary referral center for head and neck surgery.

Patients  Consecutive patients younger than 80 years with planned surgery for carcinoma of the oral cavity, pharynx, or larynx were enrolled. Patients with diabetes, those who had received antibiotics within 1 week before surgery, and those with preexisting pulmonary disease were excluded.

Intervention  Patients were randomly assigned no antibiotics or a 5-day course of intravenous amoxicillin–clavulanic acid postoperatively.

Main Outcome Measures  The development of pulmonary complications (pulmonary infection or atelectasis).

Results  Eighty-six patients were enrolled; 73 patients met the criteria for analysis. Thirty-four (47%) developed pulmonary complications; 29 (40%) had a pulmonary infection. An extended course of antibiotics did not reduce the rate of pulmonary infections (P = .57). Positive risk factors for a pulmonary infection were presence of preoperative obstructive lung function and postoperative atelectasis.

Conclusions  An extended course of antibiotics did not prevent the development of postoperative pulmonary infections in patients undergoing major head and neck surgery with tracheostomy. Poor pulmonary function and postoperative atelectasis emerged as significant risk factors for pulmonary infection.

From the Department of Otolaryngology/Head and Neck Surgery, Green Lane Hospital, Auckland District Health Board, Auckland, New Zealand. The authors have no relevant financial interest in this article.