title: 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.
abstract: 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.
authors.affiliation: Department of Surgery, National Cancer Center Hospital, 1-1 Tsukiji 5-chome, Chuo-ku, Tokyo 104-0045, Japan. sfujita@ncc.go.jp
authors.forename: Shin
authors.initials: S
authors.lastname: Fujita
authors.forename: Norio
authors.initials: N
authors.lastname: Saito
authors.forename: Tetsuji
authors.initials: T
authors.lastname: Yamada
authors.forename: Yasumasa
authors.initials: Y
authors.lastname: Takii
authors.forename: Ken
authors.initials: K
authors.lastname: Kondo
authors.forename: Masayuki
authors.initials: M
authors.lastname: Ohue
authors.forename: Eiichi
authors.initials: E
authors.lastname: Ikeda
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Moriya
mesh_terms: 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
chemical_list: D000890:Anti-Infective Agents; D008795:Metronidazole; D015311:Cefmetazole