Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
NCT ID: NCT03269994
Last Updated: 2025-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
967 participants
INTERVENTIONAL
2017-11-21
2025-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cefoxitin
Cefoxitin
Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
Piperacillin-tazobactam
Piperacillin-tazobactam
Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
Interventions
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Cefoxitin
Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
Piperacillin-tazobactam
Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Indiana University
OTHER
Massachusetts General Hospital
OTHER
Thomas Jefferson University
OTHER
Washington University School of Medicine
OTHER
Advocate Illinois Masonic Medical Center
OTHER
Baptist Memorial Health Care Corporation
OTHER
Baylor Scott and White Health
OTHER
The Cleveland Clinic
OTHER
Emory University
OTHER
Fox Chase Cancer Center
OTHER
Gundersen Lutheran Medical Center
UNKNOWN
Hackensack Meridian Health
OTHER
Hamilton Health Sciences Center
UNKNOWN
Intermountain Health Care, Inc.
OTHER
Jersey Shore Medical Center (Hackensack Meridian)
UNKNOWN
Johns Hopkins University
OTHER
Montefiore Medical Center/Albert Einstein College of Medicine
UNKNOWN
North Shore University HealthSystem
UNKNOWN
Milton S. Hershey Medical Center
OTHER
Rhode Island Hospital
OTHER
Stony Brook Medicine
UNKNOWN
Sunnybrook Health Sciences Centre, Canada
UNKNOWN
Temple University
OTHER
Ohio State University
OTHER
The Ottowa Hospital/University of Ottowa
UNKNOWN
University of California, Davis
OTHER
University of Chicago
OTHER
University of Iowa
OTHER
University of Texas Southwestern Medical Center
OTHER
University of Utah
OTHER
University of Wisconsin, Madison
OTHER
Providence Health & Services
OTHER
Albany Medical College
OTHER
Northwestern University
OTHER
Universtiy of Mississippi Medical Center
UNKNOWN
Mount Sinai Hospital, New York
OTHER
Brody School of Medicine at East Carolina University
UNKNOWN
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michael D'Angelica, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Northwestern Medicine (Data Collection)
Chicago, Illinois, United States
NorthShore University Health System
Evanston, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Washington School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States
Hackensack Meridian Health / Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States
Memoral Sloan Kettering Westchester (Consent only)
Harrison, New York, United States
Mount Sinai Hospital
New York, New York, United States
Mount Sinai West
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Health Systems (Montefiore Medical Center)
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Providence Health & Services (Portland Med Ctr)
Portland, Oregon, United States
Pennsylvania State Hershey
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Baptist Memorial Healthcare
Memphis, Tennessee, United States
Baylor Scott & White Health
Dallas, Texas, United States
Intermountain Healthcare
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
Hamilton Health Sciences Center (Juravinski Hospital)
Hamilton, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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References
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D'Angelica MI, Ellis RJ, Liu JB, Brajcich BC, Gonen M, Thompson VM, Cohen ME, Seo SK, Zabor EC, Babicky ML, Bentrem DJ, Behrman SW, Bertens KA, Celinski SA, Chan CHF, Dillhoff M, Dixon MEB, Fernandez-Del Castillo C, Gholami S, House MG, Karanicolas PJ, Lavu H, Maithel SK, McAuliffe JC, Ott MJ, Reames BN, Sanford DE, Sarpel U, Scaife CL, Serrano PE, Smith T, Snyder RA, Talamonti MS, Weber SM, Yopp AC, Pitt HA, Ko CY. Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial. JAMA. 2023 May 9;329(18):1579-1588. doi: 10.1001/jama.2023.5728.
Nevarez NM, Brajcich BC, Liu J, Ellis R, Ko CY, Pitt HA, D'Angelica MI, Yopp AC. Cefoxitin versus piperacillin-tazobactam as surgical antibiotic prophylaxis in patients undergoing pancreatoduodenectomy: protocol for a randomised controlled trial. BMJ Open. 2021 Mar 4;11(3):e048398. doi: 10.1136/bmjopen-2020-048398.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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17-418
Identifier Type: -
Identifier Source: org_study_id
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