Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Cancer, Gastrointestinal, Pancreatic Cancer
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:August 28, 2017
End Date:August 28, 2020
Contact:Michael D'Angelica, MD
Email:dangelim@mskcc.org
Phone:212-639-3226

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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

The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or
piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after
pancreatoduodenectomy.


Inclusion Criteria:

- Age >/= 18 years

- Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication

Exclusion Criteria:

- Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD

- Patients with known and documented allergies to any of the penicillins,
cephalosporins, or β-lactamase inhibitors

- Patients who are otherwise ineligible to receive the antibiotics in this study

- Patients highly unlikely to undergo PD according to the surgeon's judgment, such as
conditions amenable to pancreas enucleation, ampullectomy, etc.

- Patients with long-term glucocorticosteroid use. The following uses of corticosteroids
are permitted: single doses, topical applications (e.g., for rash), inhaled sprays
(e.g., for obstructive airways diseases), eye drops or local injections (e.g.,
intra-articular)

- Patients unable to provide informed consent

- Creatinine clearance (CrCl)
- Patients receiving hemodialysis or peritoneal dialysis

- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test

- Patients with a known bacterial infection present at the time of surgery or who
received antimicrobial therapy within 7 days prior to surgery
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New York, New York 10021
Principal Investigator: Michael D'Angelica, MD
Phone: 212-639-3226
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