search
Back to results

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

Primary Purpose

Pancreatic Cancer, Pancreas Cancer, Pancreatic Diseases

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cefoxitin
Piperacillin-tazobactam
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatoduodenectomy, 17-418, cefoxitin, piperacillin-tazobactam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Comprehensive Cancer Center
  • Emory University School of Medicine
  • Northwestern Medicine (Data Collection)
  • NorthShore University Health System
  • Indiana University
  • University of Iowa
  • Massachusetts General Hospital
  • University of Washington School of Medicine
  • University of Nebraska Medical Center
  • Memorial Sloan Kettering Basking Ridge (Consent only)
  • Hackensack Meridian Health / Hackensack University Medical Center Cancer Center
  • Montefiore Health Systems (Montefiore Medical Center)
  • Memorial Sloan Kettering Commack (Consent only)
  • Memoral Sloan Kettering Westchester (Consent only)
  • Mount Sinai Hospital
  • Mount Sinai West
  • Memorial Sloan Kettering Cancer Center
  • Duke University
  • Brody School of Medicine at East Carolina University
  • Ohio State University
  • Providence Health & Services (Portland Med Ctr)
  • Pennsylvania State Hershey
  • Thomas Jefferson University Hospital
  • Baptist Memorial Healthcare
  • Baylor Scott & White Health
  • Intermountain Healthcare
  • University of Utah
  • Gundersen Lutheran Medical Foundation
  • University of Wisconsin
  • Hamilton Health Sciences Center (Juravinski Hospital)
  • Ottawa Hospital
  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cefoxitin

Piperacillin-tazobactam

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2017
Last Updated
July 6, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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
search

1. Study Identification

Unique Protocol Identification Number
NCT03269994
Brief Title
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
Official Title
A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
August 28, 2024 (Anticipated)
Study Completion Date
August 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pancreas Cancer, Pancreatic Diseases
Keywords
pancreatoduodenectomy, 17-418, cefoxitin, piperacillin-tazobactam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
962 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cefoxitin
Arm Type
Active Comparator
Arm Title
Piperacillin-tazobactam
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cefoxitin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Piperacillin-tazobactam
Intervention Description
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 Measure Information:
Title
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
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D'Angelica, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern Medicine (Data Collection)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Washington School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Hackensack Meridian Health / Hackensack University Medical Center Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Montefiore Health Systems (Montefiore Medical Center)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Consent only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memoral Sloan Kettering Westchester (Consent only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Brody School of Medicine at East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Providence Health & Services (Portland Med Ctr)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Pennsylvania State Hershey
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Baptist Memorial Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Baylor Scott & White Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Intermountain Healthcare
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Gundersen Lutheran Medical Foundation
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Hamilton Health Sciences Center (Juravinski Hospital)
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33664081
Citation
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.
Results Reference
derived
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs