bone tumor sarcoma
Conditions
Interventions
Long term (5 days) versus short term (24 hours) postoperative (cefazolin)
antibiotics.
Sponsors
McMaster University
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of a surgical site infection within 12 months following the initial surgical procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of this study are to determine the influence of the antibiotic regimen on the development of antibiotic-related complications (ie: gastrointestinal infections, fungal infections, etc.), functional outcomes and quality of life, the rate of re-operations, oncological recurrence and/or metastases , and mortality after one year. | — |
Countries
Netherlands
Outcome results
None listed