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

  • Interventional
  • Not Recruiting
  • NCT03269994
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03269994

IRB#IRB18-0240

Lead SponsorMemorial Sloan Kettering Cancer Center

Lead PhysicianKevin K. Roggin

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting