Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)

Status: Recruiting
Phase: Phase 3
Diagnosis: Sarcoma
NCT ID: NCT01479283 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-222

 

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.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Children's Hospital Boston, Massachusetts General Hospital

Overall PI:
Megan Anderson, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - primary malignant or aggressive benign bone tumors of the lower extremity - treated by surgical excision and endoprosthetic replacement 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) - prior surgery within the surgical field of the affected limb - 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 allograft - enrolled in a competing study
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