Antimicrobial prophylaxis in pancreatoduodenectomy
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
59.0% male
N = 778
778 patients (322 female, 456 male)
Inclusion criteria: adult patients 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)
Primary outcome
Rate of postoperative surgical site infection within 30 days
19.8
32.8
32.8 %
24.6 %
16.4 %
8.2 %
0.0 %
Piperacillin/tazobactam
Cefoxitin
Significant decrease ▼
NNT = 7
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 adult patients 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.
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