EUCTR2013-004447-23-FI进行中（未招募）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
Tays0 个研究点目标入组 1,042 人开始时间: 2014年2月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,042
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1)Men and women of skeletal maturity (15 years of age or older);
- •2)Primary bone malignancies or benign aggressive tumors of the lower extremity;
- •3)Treatment by excision and endoprosthetic reconstruction;
- •4)Preoperative chemotherapy (non-compulsory);
- •5)Provision of informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1)Methicillin-resistant Staphylococcus Aureus (MRSA), or Vancomycin Resistant Enterococcus (VRE) colonization*;
- •2)Allergy to study antibiotics Zinacef® (cefuroxime)];
- •3)Skeletal immaturity**;
- •4)Upper extremity endoprosthetic reconstruction;
- •5)Prior surgery in the affected limb (excluding a biopsy);
- •6)Revision surgery or prior infection in the limb***
- •7)Enrolled in a competing study
研究者
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Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center Randomized Controlled Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections with Endoprosthetic Replacements100040181002838910005944sarcomabone tumorNL-OMON47195McMaster University40
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Clinical study in which patients with bone cancer in the leg and who are undergoing surgery to remove the tumor and reconstruct the leg using a metal implant are randomly assigned to 1 of 2 antibiotic regimens.* Patients with a primary bone malignancy or soft-tissue sarcoma that has invaded a lower extremity bone that are undergoing surgical treatment to resect the tumor and functionally reconstruct the limb using a modular metallic and polyethylene endoprosthetic implant to replace the surgically resected bones and joints. * Development of a surgical site infection according to the guidelines established by the Centers for Disease Control and Prevention (CDC)MedDRA version: 20.0Level: PTClassification code 10064736Term: Antibiotic prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.1Level: LLTClassification code 10056641Term: Post procedural site wound infectionSystem Organ Class: 100000004862MedDRA version: 20.1Level: PTClassification code 10068943Term: Limb reconstructive surgerySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10036894Term: Prophylactic antibiotic therapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10005978Term: Bone lesion excisionSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10073235Term: Bone prosthesis insertionSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10006007Term: Bone sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-004961-26-ATMcMaster University600
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