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A Phase III Multicenter Open Label Randomized Controlled Trial of Cefoxitin versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy

Investigating Investigational Antibiotics for Preventing Infections After Surgery

Recruiting
18 years and older
All
Phase N/A

This study investigates the effectiveness of two antibiotics, cefoxitin and piperacillin-tazobactam, in preventing infections at the site of surgery after a procedure called pancreatoduodenectomy. A pancreatoduodenectomy is a surgery to remove part of the pancreas and nearby organs. The study uses data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) to ensure accurate comparisons.

Participants in the study will be randomly assigned to receive either cefoxitin or piperacillin-tazobactam before their surgery. Cefoxitin is approved by the FDA for preventing infections during surgery, while piperacillin-tazobactam is commonly used for this purpose but is not specifically approved for it.

  • Who can participate: Participants should be adults who are scheduled to undergo a pancreatoduodenectomy and meet other health criteria as determined by the study.
  • Study details: Participants will receive one of the investigational antibiotics before their surgery. One is an approved antibiotic for surgery, while the other is used off-label for this purpose. A placebo will not be used in this study.
Study details
    Pancreatic Disease
    Pancreatic Cancer

TX8823

19 February 2024

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