Status:
COMPLETED
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Orthopedic Research and Education Foundation
The Physicians' Services Incorporated Foundation
Conditions:
Infection
Bone Neoplasms
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 b...
Detailed Description
Long-bone sarcomas were historically managed with amputation. In the current era of osteosarcoma management, amputations are generally avoided by complex surgeries in which the malignancy is removed a...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT01479283
Start Date
January 1 2013
End Date
March 1 2021
Last Update
March 11 2021
Active Locations (54)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90404
3
Stanford University Hospital and Clinics
Redwood City, California, United States, 94063
4
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817