NL-OMON47195招募中不适用
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 - PARITY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •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
排除标准
- •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
- •9) Enrolled or previously randomized in a competing study
- •10)Patients who weigh less than or equal to 45kg
研究者
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