Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
Trial ID or NCT#
Status
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
Eligibility 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.
- - 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).
Investigator(s)
View on ClinicalTrials.gov