Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)

Recruiting

Trial ID: NCT01479283

Age - 12 Years-N/A Gender - All Accepting Healthy Volunteers - No

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
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).

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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

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