A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 967
- Locations
- 32
- Primary Endpoint
- Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Cefoxitin
Intervention: Cefoxitin (Drug)
Piperacillin-tazobactam
Intervention: Piperacillin-tazobactam (Drug)
Outcomes
Primary Outcomes
Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.
Time Frame: 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 Outcomes
No secondary outcomes reported