In this open-label phase III study, the researchers compared the incidence of surgical-site infections with intra-operative antimicrobial prophylaxis alone versus intra-operative plus postoperative administration in Japanese patients with gastric cancer that was potentially curable with a distal gastrectomy.
A total of 355 patients were randomised to either intraoperative antimicrobial prophylaxis alone (cefazolin 1 g before the surgical incision and every 3 hours as intraoperative supplements; n=176) or extended antimicrobial prophylaxis (intraoperative administration plus cefazolin 1 g once after closure and twice daily for 2 postoperative days; n=179). The primary endpoint was the incidence of surgical-site infections.
Eight patients (5%, 95% CI 2—9%) had surgical-site infections in the intraoperative group compared with 16 (9%, 5—14) in the extended group. The relative risk of surgical-site infections with intraoperative antimicrobial prophylaxis was 0•51 (0.22—1.16), which revealed statistically significant non-inferiority (p<0.0001).
The researchers concluded that based on their findings, they do not recommend antimicrobial prophylaxis after gastric cancer surgery.
An accompanying editorial discusses the findings from this study.