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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 3

Conditions

Pancreatic Diseases

Pancreas Cancer

Pancreatic Cancer

Treatments

Drug: Cefoxitin

Drug: Piperacillin-tazobactam

Study type

Interventional

Funder types

Other

Identifiers

NCT03269994

17-418

Details and patient eligibility

About

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.

Enrollment

967 patients

Sex

All

Ages

18+ years old

Volunteers

No 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