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

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.

Conditions

• Pancreatic Cancer
• Pancreas Cancer
• Pancreatic Diseases

Interventions

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.

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.

Sponsors & Collaborators

• Indiana University

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Advocate Illinois Masonic Medical Center

  collaborator OTHER

• Baptist Memorial Health Care Corporation

  collaborator OTHER

• Baylor Scott and White Health

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Emory University

  collaborator OTHER

• Fox Chase Cancer Center

  collaborator OTHER

• Gundersen Lutheran Medical Center

  collaborator UNKNOWN

• Hackensack Meridian Health

  collaborator OTHER

• Hamilton Health Sciences Center

  collaborator UNKNOWN

• Intermountain Health Care, Inc.

  collaborator OTHER

• Jersey Shore Medical Center (Hackensack Meridian)

  collaborator UNKNOWN

• Johns Hopkins University

  collaborator OTHER

• Montefiore Medical Center/Albert Einstein College of Medicine

  collaborator UNKNOWN

• North Shore University HealthSystem

  collaborator UNKNOWN

• Milton S. Hershey Medical Center

  collaborator OTHER

• Rhode Island Hospital

  collaborator OTHER

• Stony Brook Medicine

  collaborator UNKNOWN

• Sunnybrook Health Sciences Centre, Canada

  collaborator UNKNOWN

• Temple University

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• The Ottowa Hospital/University of Ottowa

  collaborator UNKNOWN

• University of California, Davis

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• Providence Health & Services

  collaborator OTHER

• Albany Medical College

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• Universtiy of Mississippi Medical Center

  collaborator UNKNOWN

• Mount Sinai Hospital, New York

  collaborator OTHER

• Brody School of Medicine at East Carolina University

  collaborator UNKNOWN

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Michael D'Angelica, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-21

Primary Completion

2025-01-28

Completion

2025-01-28

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations