Trial Search Results

Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

McMaster University

Collaborator: Canadian Institutes of Health Research (CIHR)

Stanford Investigator(s):

Intervention(s):

  • Drug: 24-Hour Prophylactic Cefazolin* Antibiotic Regimen
  • Drug: 5-Days Prophylactic Cefazolin* Antibiotic Regimen

Phase:

Phase 3

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).

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting