Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)

Summary

The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial is the first ever international multi-center randomized controlled trial in bone cancer surgery. In order to avoid amputation for bone cancer in the leg, complex limb-saving operations are performed. However, infections with devastating complications following surgery are common. Surgeons from across the world will randomize patients to receive either short- or long-duration antibiotic regimens after surgery with the goal of identifying the best regimen to reduce these infections.

Conditions

• Infection
• Bone Neoplasms

Interventions

DRUG

24-Hour Prophylactic Cefazolin* Antibiotic Regimen

Pre-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin within 60 minutes prior to the procedure. No other pre-operative antibiotics will be administered. Intra-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin every 3-4 hours. No other intra-operative antibiotics will be administered. Post-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin every 8 hours for 24 hours followed by IV saline for 4 days. No other post-operative antibiotics will be administered.

DRUG

5-Days Prophylactic Cefazolin* Antibiotic Regimen

Pre-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin within 60 minutes prior to the procedure. No other pre-operative antibiotics will be administered. Intra-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin every 3-4 hours. No other intra-operative antibiotics will be administered. Post-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin every 8 hours for 5 days. No other post-operative antibiotics will be administered.

Sponsors & Collaborators

• Orthopedic Research and Education Foundation

  collaborator OTHER

• The Physicians' Services Incorporated Foundation

  collaborator OTHER

• Canadian Cancer Society (CCS)

  collaborator OTHER

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• McMaster University

  lead OTHER

Principal Investigators

• Michelle Ghert, MD, FRCSC · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2021-03-31

Completion

2021-03-31

Countries

• United States
• Argentina
• Australia
• Austria
• Brazil
• Canada
• Egypt
• India
• Netherlands
• Singapore
• South Africa
• Spain

Study Locations