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

Phase 3

Completed

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.

Recruitment & 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 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

Arm && Interventions

Group	Intervention	Description
Cefoxitin	Cefoxitin	-
Piperacillin-tazobactam	Piperacillin-tazobactam	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.	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

Locations (32): UC Davis Comprehensive Cancer Center
🇺🇸
Sacramento, California, United States
Emory University School of Medicine
🇺🇸
Atlanta, Georgia, United States
Northwestern Medicine (Data Collection)
🇺🇸
Chicago, Illinois, United States
NorthShore University Health System
🇺🇸
Evanston, Illinois, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
University of Iowa
🇺🇸
Iowa City, Iowa, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of Washington School of Medicine
🇺🇸
St Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
Memorial Sloan Kettering Basking Ridge (Consent only)
🇺🇸
Basking Ridge, New Jersey, United States
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UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States