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

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ClinicalTrials.gov Identifier: NCT03269994
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : September 9, 2021
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

Tracking Information
First Submitted Date  ICMJE August 30, 2017
First Posted Date  ICMJE September 1, 2017
Last Update Posted Date September 9, 2021
Actual Study Start Date  ICMJE August 28, 2017
Estimated Primary Completion Date August 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
Official Title  ICMJE A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Cancer
  • Pancreas Cancer
  • Pancreatic Diseases
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Cefoxitin
    Intervention: Drug: Cefoxitin
  • Experimental: Piperacillin-tazobactam
    Intervention: Drug: Piperacillin-tazobactam
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 28, 2022
Estimated Primary Completion Date August 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael D'Angelica, MD 212-639-3226 dangelim@mskcc.org
Contact: Peter Kingham, MD 212-639-5260 kinghamt@mskcc.org
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03269994
Other Study ID Numbers  ICMJE 17-418
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Michael D'Angelica, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP