Can preoperative antibiotics take the place of postoperative long period antibiotics on the surgical site infection in Japan? – A phase II study by Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) in Japan

Abstract

4162 [Background] A prospective randomized controlled study showed that preoperative administration of antibiotics reduced the risk of wound infection after clean-contaminated surgical procedures more effectively than postoperative administration (N Engl J Med 1992;326:281–286) In Japan, large number of patients undergoing the clean-contaminated surgical procedures receive postoperative administration of antibiotics for a few days and the incidence of surgical site infection (SSI) is 5–10%. [Methods] A preoperative antibiotics administration to the patients with gastric cancer was studied on SSI in a multi-institutional phase II study. A one gram of Cefazoline diluted by 100 ml of saline was administered to the patients at the start of anesthesia. When the operation lasted more than 3 hours, an additional perioperative Cefazoline was administered. Eligibility Criteria: (1) histologically proven gastric cancer, (2) undergoing distal gastrectomy, (3) D2 lymphadenectomy, (4) clean-contaminated surgical procedures, (5) written informed consent. Exclusion Criteria: preexisting infection. Surgical Site Infection: For 30 days after operation, the infection control team graded the wound according to CDC guideline. Endpoints: The primary endpoint is the incidence of SSI, and the secondary endpoint is the incidence of distant site infection. [Results] A total of 56 patients have been registered between November 2002 and April 2003. A deep incisional SSI, an organ SSI and urinary tract infection were observed in one, two and one patients, respectively. The SSI rate was 5.4% (3/56). Before this series, the incidence of SSI following 3 days of postoperative antibiotics was 4.8% (3/62). There is no difference between the two groups (p=0.05). [Conclusion] A preoperative low dose antibiotics was feasible and showed the same SSI rate as postoperative high dose antibiotics. A phase III study is necessary to confirm a low incidence of SSI of preoperative antibiotics administration in comparison with that of postoperative antibiotics in Japan. No significant financial relationships to disclose.