6/28/23, 12:52 AM Antimicrobial prophylaxis in pancreatoduodenectomy Pathway Feedback Search Clinical Topics Home Studies Antimicrobial prophylaxis in pancreatoduodenectomy Antimicrobial prophylaxis in pancreatoduodenectomy Disease Disease Disease Ampullary cancer Duodenal trauma Neoplastic Trial question Is piperacillin-tazobactam antimicrobial prophylaxis superior to cefoxitin in patients undergoing open pancreatoduodenectomy? Study design Multi-center Open label RCT Population Characteristics of study participants 41.0% female N = 778 59.0% male 778 patients (322 female, 456 male) Inclusion criteria: adults undergoing open pancreatoduodenectomy for any indication Key exclusion criteria: allergies to study medications; active infections; chronic steroid use; significant kidney dysfunction; or pregnancy/breastfeeding Interventions N=378 piperacillin-tazobactam (intravenous infusion of 3.375 or 4.5 g within 60 minutes of incision and every 2-4 hours during operation until incision closing) N=400 cefoxitin (intravenous infusion of 2 g within 60 minutes of incision and every 2-4 hours during operation until incision closing) https://web.pathway.md/studies/recqjPr0tlcAivyCW 1/2 6/28/23, 12:52 AM Antimicrobial prophylaxis in pancreatoduodenectomy Pathway Primary outcome Rate of postoperative surgical site infection within 30 days 32.8 % 32.8 24.6 % 19.8 16.4 % Significant decrease 8.2 % NNT = 8 0.0 % Piperacillin-tazobactam Cefoxitin Significant decrease in the rate of postoperative surgical site infection within 30 days (19.8% vs. 32.8%; OR 0.51, 95% CI 0.38 to 0.68) Secondary outcomes No significant difference in death at day 30 (1.3% vs. 2.5%; OR 0.52, 95% CI 0.14 to 1.93) Significant decrease in postoperative sepsis (4.2% vs. 7.5%; OR 0.55, 95% CI 0.32 to 0.92) Significant decrease in postoperative pancreatic fistula (12.7% vs. 19%; OR 0.62, 95% CI 0.4 to 0.96) Conclusion In adults undergoing open pancreatoduodenectomy for any indication, piperacillin-tazobactam was superior to cefoxitin with respect to the rate of postoperative surgical site infection within 30 days. Reference Michael I D'Angelica, Ryan J Ellis, Jason B Liu et al. Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial. JAMA. 2023 May 9;329(18):1579-1588. Open reference URL https://web.pathway.md/studies/recqjPr0tlcAivyCW 2/2