Randomized, multicenter trial of antibiotic prophylaxis in elective colorectal surgery: single dose vs 3 doses of a second-generation cephalosporin without metronidazole and oral antibiotics.
OBJECTIVE
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.


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


METHODS
Seven major hospitals in Japan that offer cancer treatment.


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


METHODS
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.


METHODS
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.


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


BACKGROUND
clinicaltrials.gov Identifier: NCT00292708.
Fujita
Shin
S
Department of Surgery, National Cancer Center Hospital, 1-1 Tsukiji 5-chome, Chuo-ku, Tokyo 104-0045, Japan. sfujita@ncc.go.jp
Saito
Norio
N
Yamada
Tetsuji
T
Takii
Yasumasa
Y
Kondo
Ken
K
Ohue
Masayuki
M
Ikeda
Eiichi
E
Moriya
Yoshihiro
Y
D000284:Administration, Oral; D000890:Anti-Infective Agents; D019072:Antibiotic Prophylaxis; D015311:Cefmetazole / Q000008:administration & dosage*; D003082:Colectomy; D003110:Colonic Neoplasms / Q000601:surgery*; D004334:Drug Administration Schedule; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D007415:Intestinal Obstruction / Q000209:etiology; D010535:Laparoscopy; D007902:Length of Stay; D008297:Male; D008795:Metronidazole; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000601:surgery*; D012007:Rectum / Q000601:surgery; D013530:Surgical Wound Infection / Q000209:etiology
D000890:Anti-Infective Agents; D008795:Metronidazole; D015311:Cefmetazole