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Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
Trial ID: NCT01479283
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.
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
- 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
- treatment by surgical excision and endoprosthetic replacement of the femur or tibia.
- 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
- known renal insufficiency with estimated creatinine clearance (eGRF) of less than 54
- 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).
drug: 24-Hour Prophylactic Cefazolin* Antibiotic Regimen
drug: 5-Days Prophylactic Cefazolin* Antibiotic Regimen
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