Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
- Conditions
- Pancreas CancerPancreatic DiseasesPancreatic Cancer
- Interventions
- Registration Number
- NCT03269994
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 958
- Age >/= 18 years
- Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
- 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 ฮฒ-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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cefoxitin Cefoxitin - Piperacillin-tazobactam Piperacillin-tazobactam -
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Emory University School of Medicine
๐บ๐ธAtlanta, Georgia, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
Hackensack Meridian Health / Hackensack University Medical Center Cancer Center
๐บ๐ธHackensack, New Jersey, United States
Northwestern Medicine (Data Collection)
๐บ๐ธChicago, Illinois, United States
University of Washington School of Medicine
๐บ๐ธSaint Louis, Missouri, United States
Indiana University
๐บ๐ธIndianapolis, Indiana, United States
University of Iowa
๐บ๐ธIowa City, Iowa, United States
Memorial Sloan Kettering Cancer Center
๐บ๐ธNew York, New York, United States
Memorial Sloan Kettering Commack (Consent only)
๐บ๐ธCommack, New York, United States
NorthShore University Health System
๐บ๐ธEvanston, Illinois, United States
Brody School of Medicine at East Carolina University
๐บ๐ธGreenville, North Carolina, United States
Memoral Sloan Kettering Westchester (Consent only)
๐บ๐ธHarrison, New York, United States
Ohio State University
๐บ๐ธColumbus, Ohio, United States
Duke University
๐บ๐ธDurham, North Carolina, United States
University of Wisconsin
๐บ๐ธMadison, Wisconsin, United States
University of Utah
๐บ๐ธSalt Lake City, Utah, United States
Providence Health & Services (Portland Med Ctr)
๐บ๐ธPortland, Oregon, United States
University of Nebraska Medical Center
๐บ๐ธOmaha, Nebraska, United States
Thomas Jefferson University Hospital
๐บ๐ธPhiladelphia, Pennsylvania, United States
UC Davis Comprehensive Cancer Center
๐บ๐ธSacramento, California, United States
Memorial Sloan Kettering Basking Ridge (Consent only)
๐บ๐ธBasking Ridge, New Jersey, United States
Mount Sinai Hospital
๐บ๐ธNew York, New York, United States
Mount Sinai West
๐บ๐ธNew York, New York, United States
Pennsylvania State Hershey
๐บ๐ธHershey, Pennsylvania, United States
Baptist Memorial Healthcare
๐บ๐ธMemphis, Tennessee, United States
Baylor Scott & White Health
๐บ๐ธDallas, Texas, United States
Gundersen Lutheran Medical Foundation
๐บ๐ธLa Crosse, Wisconsin, United States
Intermountain Healthcare
๐บ๐ธMurray, Utah, United States
Ottawa Hospital
๐จ๐ฆOttawa, Ontario, Canada
Hamilton Health Sciences Center (Juravinski Hospital)
๐จ๐ฆHamilton, Ontario, Canada
Sunnybrook Health Sciences Centre
๐จ๐ฆToronto, Ontario, Canada
Montefiore Health Systems (Montefiore Medical Center)
๐บ๐ธBronx, New York, United States