Status:
COMPLETED
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Indiana University
Massachusetts General Hospital
Conditions:
Pancreatic Cancer
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 pancreatoduodenectom...
Eligibility Criteria
Inclusion
- Age \>/= 18 years
- Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
Exclusion
- 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
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2025
Estimated Enrollment :
967 Patients enrolled
Trial Details
Trial ID
NCT03269994
Start Date
November 21 2017
End Date
January 28 2025
Last Update
October 21 2025
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
2
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
3
Northwestern Medicine (Data Collection)
Chicago, Illinois, United States, 60611
4
NorthShore University Health System
Evanston, Illinois, United States, 60201