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Single Dose vs 3 Doses of a Second-Generation Cephalosporin Without Metronidazole and Oral Antibiotics

Shin Fujita, MD; Norio Saito, MD; Tetsuji Yamada, MD; Yasumasa Takii, MD; Ken Kondo, MD; Masayuki Ohue, MD; Eiichi Ikeda, MD; Yoshihiro Moriya, MD

Arch Surg. 2007;142(7):657-661.

Hypothesis  Use of prophylactic antibiotics in elective colorectal surgery is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a multicenter, randomized trial of a single dose vs 3 doses of the second-generation cephalosporin cefmetazole.

Design  A prospective, randomized, multicenter trial in patients undergoing elective colorectal surgery.

Setting  Seven major hospitals in Japan that offer cancer treatment.

Patients  Patients with colorectal cancer treated from May 6, 2004, to April 25, 2005.

Interventions  Patients were randomized to 1 of 2 groups: a single-dose group given a single dose of cefmetazole just before skin incision and a 3-dose group given 2 additional doses of cefmetazole every 8 hours after the first dose just before skin incision.

Main Outcome Measures  Incidences of incisional surgical site infection (SSI), organ or space SSI, and all other infectious complications within 30 days after surgery.

Results  A total of 384 patients were enrolled. Seven patients were excluded because of additional surgery or the inability to tolerate mechanical preparation. The incidence of incisional SSI was higher in the single-dose group (27/190 or 14.2%) than in the 3-dose group (8/187 or 4.3%) (P = .009). Incidences of organ or space SSI and other postoperative infectious diseases did not differ significantly between the 2 groups. In multivariate analysis, antibiotic dose was the only significant factor related to the incidence of incisional SSI.

Conclusion  Three-dose cefmetazole administration is significantly more effective for prevention of incisional SSI than single-dose antibiotic administration.

Trial Registration  clinicaltrials.gov Identifier: NCT00292708

Author Affiliations: Department of Surgery, National Cancer Center Hospital, Tokyo, Japan (Drs Fujita and Moriya), National Cancer Center Hospital East, Chiba, Japan (Dr Saito), Ishikawa Prefectural Central Hospital, Ishikawa, Japan (Dr Yamada), Niigata Cancer Center Hospital, Niigata, Japan (Dr Takii), Nagoya Medical Center, Nagoya, Japan (Dr Kondo), Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan (Dr Ohue), and Yamagata Prefectural Central Hospital, Yamagata, Japan (Dr Ikeda).