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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03269994

Collaborator

Indiana University (Other), Massachusetts General Hospital (Other), Thomas Jefferson University (Other), Washington University School of Medicine (Other), Advocate Illinois Masonic Medical Center (Other), Baptist Memorial Health Care Corporation (Other), Baylor Scott and White Health (Other), The Cleveland Clinic (Other), Emory University (Other), Fox Chase Cancer Center (Other), Gundersen Lutheran Medical Center (Other), Hackensack Meridian Health (Other), Hamilton Health Sciences Center (Other), Intermountain Health Care, Inc. (Other), Jersey Shore Medical Center (Hackensack Meridian) (Other), Johns Hopkins University (Other), Montefiore Medical Center/Albert Einstein College of Medicine (Other), North Shore University HealthSystem (Other), Milton S. Hershey Medical Center (Other), Rhode Island Hospital (Other), Stony Brook Medicine (Other), Sunnybrook Health Sciences Centre, Canada (Other), Temple University (Other), The Ohio State University Wexner Medical Center (Other), The Ottowa Hospital/University of Ottowa (Other), University of California, Davis (Other), University of Chicago (Other), University of Iowa (Other), University of Texas Southwestern Medical Center (Other), University of Utah (Other), University of Wisconsin, Madison (Other), Providence Health & Services (Other), Albany Medical College (Other), Northwestern University (Other), Universtiy of Mississippi Medical Center (Other), Mount Sinai Hospital, New York (Other), Brody School of Medicine at East Carolina University (Other)

962

Enrollment

Locations

Arms

69.2

Anticipated Duration (Months)

30.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Pancreas Cancer Pancreatic Diseases	Drug: Cefoxitin Drug: Piperacillin-tazobactam	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

962 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 21, 2017

Anticipated Primary Completion Date :

Aug 28, 2023

Anticipated Study Completion Date :

Aug 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cefoxitin	Drug: Cefoxitin Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
Experimental: Piperacillin-tazobactam	Drug: Piperacillin-tazobactam Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.

Arm

Intervention/Treatment

Active Comparator: Cefoxitin

Drug: Cefoxitin

Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.

Experimental: Piperacillin-tazobactam

Drug: Piperacillin-tazobactam

Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.

Outcome Measures

Primary Outcome Measures

Compare the effectiveness of cefoxitin with piperacillin-tazobactam as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative surgical site infections in participants undergoing pancreatoduodenectomy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Indiana University	Indianapolis	Indiana	United States	46202
6	University of Iowa	Iowa City	Iowa	United States	52242
7	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
8	University of Washington School of Medicine	Saint Louis	Missouri	United States	63110
9	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-7680
10	Memoral Sloan Kettering Basking Ridge (Consent only)	Basking Ridge	New Jersey	United States	07920
11	Hackensack Meridian Health / Hackensack University Medical Center Cancer Center	Hackensack	New Jersey	United States	07601
12	Montefiore Health Systems (Montefiore Medical Center)	Bronx	New York	United States	10467
13	Memorial Sloan Kettering Commack (Consent only)	Commack	New York	United States	11725
14	Memoral Sloan Kettering Westchester (Consent only)	Harrison	New York	United States	10604
15	Mount Sinai Hospital	New York	New York	United States	10029
16	Mount Sinai West	New York	New York	United States	10029
17	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
18	Duke University	Durham	North Carolina	United States	27713
19	Brody School of Medicine at East Carolina University	Greenville	North Carolina	United States	27834
20	Ohio State University	Columbus	Ohio	United States	43210
21	Providence Health & Services (Portland Med Ctr)	Portland	Oregon	United States	97213
22	Pennsylvania State Hershey	Hershey	Pennsylvania	United States	17033
23	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
24	Baptist Memorial Healthcare	Memphis	Tennessee	United States	38120
25	Baylor Scott & White Health	Dallas	Texas	United States	75246
26	Intermountain Healthcare	Murray	Utah	United States	84107
27	University of Utah	Salt Lake City	Utah	United States	84112
28	Gundersen Lutheran Medical Foundation	La Crosse	Wisconsin	United States	54601
29	University of Wisconsin	Madison	Wisconsin	United States	53792
30	Hamilton Health Sciences Center (Juravinski Hospital)	Hamilton	Ontario	Canada
31	Ottawa Hospital	Ottawa	Ontario	Canada	K1H 8L6
32	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5