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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03269994
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Indiana University
Massachusetts General Hospital
Thomas Jefferson University
Washington University School of Medicine
Advocate Illinois Masonic Medical Center
Baptist Memorial Health Care Corporation
Baylor Scott and White Health
The Cleveland Clinic
Emory University
Fox Chase Cancer Center
Gundersen Lutheran Medical Center
Hackensack Meridian Health
Hamilton Health Sciences Center
Intermountain Health Care, Inc.
Jersey Shore Medical Center (Hackensack Meridian)
Johns Hopkins University
Montefiore Medical Center/Albert Einstein College of Medicine
North Shore University HealthSystem
Milton S. Hershey Medical Center
Rhode Island Hospital
Stony Brook Medicine
Sunnybrook Health Sciences Centre, Canada
Temple University
The Ohio State University Wexner Medical Center
The Ottowa Hospital/University of Ottowa
University of California, Davis
University of Chicago
University of Iowa
University of Texas Southwestern Medical Center
University of Utah
University of Wisconsin, Madison
Providence Health & Services
Albany Medical College
Northwestern University
Universtiy of Mississippi Medical Center
Mount Sinai Hospital, New York
Brody School of Medicine at East Carolina University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Pancreas Cancer Pancreatic Diseases Drug: Cefoxitin Drug: Piperacillin-tazobactam Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : August 28, 2020
Estimated Study Completion Date : August 28, 2020


Arm Intervention/treatment
Active Comparator: Cefoxitin Drug: 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.

Experimental: Piperacillin-tazobactam Drug: 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.




Primary Outcome Measures :
  1. Compare the effectiveness of cefoxitin with piperacillin-tazobactam as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative surgical site infections in participants undergoing pancreatoduodenectomy [ Time Frame: 30 days ]
    To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269994


Contacts
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Contact: Michael D'Angelica, MD 212-639-3226 dangelim@mskcc.org
Contact: Peter Kingham, MD 212-639-5260 kinghamt@mskcc.org

Locations
Show Show 29 study locations
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Indiana University
Massachusetts General Hospital
Thomas Jefferson University
Washington University School of Medicine
Advocate Illinois Masonic Medical Center
Baptist Memorial Health Care Corporation
Baylor Scott and White Health
The Cleveland Clinic
Emory University
Fox Chase Cancer Center
Gundersen Lutheran Medical Center
Hackensack Meridian Health
Hamilton Health Sciences Center
Intermountain Health Care, Inc.
Jersey Shore Medical Center (Hackensack Meridian)
Johns Hopkins University
Montefiore Medical Center/Albert Einstein College of Medicine
North Shore University HealthSystem
Milton S. Hershey Medical Center
Rhode Island Hospital
Stony Brook Medicine
Sunnybrook Health Sciences Centre, Canada
Temple University
The Ohio State University Wexner Medical Center
The Ottowa Hospital/University of Ottowa
University of California, Davis
University of Chicago
University of Iowa
University of Texas Southwestern Medical Center
University of Utah
University of Wisconsin, Madison
Providence Health & Services
Albany Medical College
Northwestern University
Universtiy of Mississippi Medical Center
Mount Sinai Hospital, New York
Brody School of Medicine at East Carolina University
Investigators
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Principal Investigator: Michael D'Angelica, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03269994    
Other Study ID Numbers: 17-418
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
pancreatoduodenectomy
17-418
cefoxitin
piperacillin-tazobactam
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatic Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Tazobactam
Piperacillin
Piperacillin, Tazobactam Drug Combination
Cefoxitin
Cefotaxime
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action