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 |
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.
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) = 40 mL/min
- 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
16
sites
136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Phone: 212-639-3226
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1648 Pierce Dr NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 727-5640
Phone: 404-778-5777
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
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-2000
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425 University Blvd.
Indianapolis, Indiana 46202
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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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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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
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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4501 X St
Sacramento, California 95817
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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