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NCT03269994 Clinical Trial

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

Pancreatic Cancer Clinical Trial

Official title:
A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03269994
Other study ID # 17-418
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 21, 2017
Est. completion date August 28, 2024

Study information
Verified date July 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 962
Est. completion date August 28, 2024
Est. primary completion date August 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 ß-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

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Canada Hamilton Health Sciences Center (Juravinski Hospital) Hamilton Ontario
Canada Ottawa Hospital Ottawa Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
United States Emory University School of Medicine Atlanta Georgia
United States Memorial Sloan Kettering Basking Ridge (Consent only) Basking Ridge New Jersey
United States Massachusetts General Hospital Boston Massachusetts
United States Montefiore Health Systems (Montefiore Medical Center) Bronx New York
United States Northwestern Medicine (Data Collection) Chicago Illinois
United States Ohio State University Columbus Ohio
United States Memorial Sloan Kettering Commack (Consent only) Commack New York
United States Baylor Scott & White Health Dallas Texas
United States Duke University Durham North Carolina
United States NorthShore University Health System Evanston Illinois
United States Brody School of Medicine at East Carolina University Greenville North Carolina
United States Hackensack Meridian Health / Hackensack University Medical Center Cancer Center Hackensack New Jersey
United States Memoral Sloan Kettering Westchester (Consent only) Harrison New York
United States Pennsylvania State Hershey Hershey Pennsylvania
United States Indiana University Indianapolis Indiana
United States University of Iowa Iowa City Iowa
United States Gundersen Lutheran Medical Foundation La Crosse Wisconsin
United States University of Wisconsin Madison Wisconsin
United States Baptist Memorial Healthcare Memphis Tennessee
United States Intermountain Healthcare Murray Utah
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mount Sinai Hospital New York New York
United States Mount Sinai West New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Providence Health & Services (Portland Med Ctr) Portland Oregon
United States UC Davis Comprehensive Cancer Center Sacramento California
United States University of Washington School of Medicine Saint Louis Missouri
United States University of Utah Salt Lake City Utah

Sponsors (38)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Advocate Illinois Masonic Medical Center, Albany Medical College, Baptist Memorial Health Care Corporation, Baylor Scott and White Health, Brody School of Medicine at East Carolina University, Emory University, Fox Chase Cancer Center, Gundersen Lutheran Medical Center, Hackensack Meridian Health, Hamilton Health Sciences Center, Indiana University, Intermountain Health Care, Inc., Jersey Shore Medical Center (Hackensack Meridian), Johns Hopkins University, Massachusetts General Hospital, Milton S. Hershey Medical Center, Montefiore Medical Center/Albert Einstein College of Medicine, Mount Sinai Hospital, New York, North Shore University HealthSystem, Northwestern University, Providence Health & Services, Rhode Island Hospital, Stony Brook Medicine, Sunnybrook Health Sciences Centre, Canada, Temple University, The Cleveland Clinic, The Ohio State University Wexner Medical Center, The Ottowa Hospital/University of Ottowa, Thomas Jefferson University, University of California, Davis, University of Chicago, University of Iowa, University of Texas Southwestern Medical Center, University of Utah, University of Wisconsin, Madison, Universtiy of Mississippi Medical Center, Washington University School of Medicine

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 30 days
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