Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborators: Canadian Cancer Society (CCS); Canadian Cancer Society Research Institute (CCSRI); Canadian Institutes of Health Research (CIHR); Orthopedic Research and Education Foundation; The Physicians' Services Incorporated Foundation
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefazolin

Criteria

Inclusion Criteria:

• primary bone malignancies or aggressive benign bone tumors of the femur or tibia, soft-tissue sarcomas which have invaded the femur or tibia, or oligometastatic bone disease of the femur or tibia in a patient expected to live at least one year post-operatively; and

• treatment by surgical excision and endoprosthetic replacement of the femur or tibia.

Exclusion Criteria:

• current known Methicillin-resistant Staphylococcus Aureus (MRSA) colonization;

• current known Vancomycin Resistant Enterococcus (VRE) colonization;

• documented anaphylaxis or angioedema to penicillin or cefazolin (Ancef);

• current surgical procedure is a revision surgery for implant failure or infection;

• prior local infection within the surgical field of the affected limb;

• current known immunologically-deficient disease conditions (not including recent chemotherapy);

• known renal insufficiency with estimated creatinine clearance (eGRF) of less than 54 mL/min;

• reconstruction to include structural allograft;

• enrolled in a competing study; and

• weight of less than or equal to 45 kg (for sites using cefuroxime only).