Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)

Trial ID or NCT#

NCT01479283

Status

not recruiting iconNOT RECRUITING

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

Ages Eligible for Study: Older than 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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).
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Investigator(s)

Raffi S. Avedian, MD
Raffi S. Avedian, MD
Orthopaedic surgical oncologist, Sarcoma specialist, Musculoskeletal tumors surgeon
Associate Professor of Orthopaedic Surgery

View on ClinicalTrials.gov