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Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
Recruiting
Trial ID: NCT01479283
Purpose
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.
Official Title
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center International Randomized Controlled Trial Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections With Endoprosthetic Replacements
Stanford Investigator(s)
Raffi S. Avedian, MD
Associate Professor of Orthopaedic Surgery
Eligibility
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).
Intervention(s):
drug: 24-Hour Prophylactic Cefazolin* Antibiotic Regimen
drug: 5-Days Prophylactic Cefazolin* Antibiotic Regimen
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305