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
We found this trial at
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 212-639-3226
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
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Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Phone: 317-944-0113
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-293-7171
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3500 Gaston Avenue
Dallas, Texas 75246
Phone: 214-820-2302
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Hamilton, Ontario
Phone: 905.521.2100
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La Crosse, Wisconsin 54601
Phone: 608-775-2331
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Madison, Wisconsin 53792
(608) 263-2400
Phone: 608-873-2266
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Memphis, Tennessee 38120
Phone: 901-226-5957
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Murray, Utah 84107
Phone: 801-507-3460
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New York, New York 10021
Principal Investigator: Michael D'Angelica, MD
Phone: 212-639-3226
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Harish Lavu, MD
Phone: 215-955-6702
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Portland, Oregon 97213
Phone: 503-215-8650
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4501 X St
Sacramento, California 95817
(916) 734-5800
Phone: 800-282-3284
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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Saint Louis, Missouri 63110
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