K-590. Randomized, Multicenter Trial of Antibiotic Prophylaxis for Abdominal Radical Hysterectomy in Patients with Uterine Cervical Cancer: Single Dose Vs 4 Doses of Cefmetazole
Session: Poster Session: Surgical Site Infections: Trials and Tribulations
Saturday, October 25, 2008: 12:00 AM
Room: Hall C
Background: Use of prophylactic antibiotics in abdominal radical hysterectomy in patients with uterine cervical cancer is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole is not fully proven. We conducted a multicenter, randomized trial of a single dose vs 4 doses of the second-generation cephalosporin cefmetazole. Methods: A prospective, randomized, multicenter trial in patients undergoing abdominal radical hysterectomy for uterine cervical cancer. Seven hospitals in Japan that offer uterine cancer treatment. Patients with uterine cervical cancer treated from January 2002 to June 2007. Patients were randomized to 1 of 2 groups: a single-dose group given a single dose of cefmetazole just before skin incision, and a 4-dose group given 3 additional doses of cefmetazole every 6 hours after the first dose just before skin incision. Incidences of incisional surgical site infection (SSI), organ/space SSI, and all other infectious complications within 30 days after surgery. Results: A total of 214 patients were enrolled. Three patients were excluded because of additional surgery. The incidence of organ/space SSI and other postoperative infectious diseases was higher in the single-dose group (9/106, 8.49%) than in the 3-dose group (2/105, 1.90%) (p<0.05). Incidences of incisional SSI did not differ significantly between the 2 groups. In multivariate analysis, antibiotic dose was the only significant factor related to the incidence of organ/space SSI. Conclusions: Multiple-dose cefmetazole administration within 24 hours after operation based on pharmacokinetics-pharmacodynamics (PK-PD) theory is significantly more effective for prevention of organ/space SSI than single-dose antibiotic administration.
Hiroshige Mikamo, MD, PhD, Aichi Medical University, Aichi-gun, Aichi, Japan, Yuka Yamagishi, MD, Aichi Medical University and  H. Mikamo, None.