Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center Randomized Controlled Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections with Endoprosthetic Replacements

Recruiting

• Conditions: bone tumor; sarcoma; 10004018; 10028389; 10005944

• Registration Number: NL-OMON47195
• Lead Sponsor: McMaster University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1) Males and females 12 years of age or older;
2) Primary bone malignancies or benign aggres sive 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;
3) Treatment by excision and en doprosthetic reconstruction*;
4) Provision of informed consent

Exclusion Criteria

1) Current known Methicillin-resistant Staphylococcus Aureus (MRSA), or Vancomycin Resistant Enterococcus (VRE) skin colonization*;
2) Documented anaphylaxis or angioedema to penicillin or the study antibiotics [cefazolin, or equivalent gram-positive coverage (i.e. cefuroxime)]
3) Prior surgery within the surgical field of the affected limb (excluding a biopsy);
4) Prior local infection within the surgical field of the limb**
5) Current known immunologically-deficient disease conditions (not including
recent chemotherapy) ***
6) Known renal insufficiency with estimated creatinine clearance (eGRF) of
less than 54 mL/min
7) Reconstruction to include allograft as well
8) Likely problems, in the judgement of the investigator, with maintaining
follow-up
9) Enrolled or previously randomized in a competing study
10)Patients who weigh less than or equal to 45kg

Study & Design

• Study Type: Interventional
• Study Design: Not specified