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临床试验/EUCTR2020-004004-34-DK
EUCTR2020-004004-34-DK进行中(未招募)1 期

Prevention of infection in orthopaedic spine surgery - a clinical study antibiotic concentrations of in spine tissue after administration of weight-dosed antibiotics - SPINE STUDY

Aarhus University Hospital0 个研究点目标入组 20 人开始时间: 2020年8月30日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

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

性别
All

入选标准

  • - Sign informed consent (and sign informed consent by parents with child custody when participants are under 18 years of age).
  • - Planned spine deformity surgery at the Department of Orthopaedic Surgery, Aarhus University Hospital
  • - Normal preoperative kidney function (assessed by eGFR, P-creatinin)
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 10
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 5
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 5

排除标准

  • - Fertile women may not be pregnant (asked about the likelihood of pregnancy at preliminary visit and offered preoperative plasma hCG for clarification if in doubt).
  • - Allergy towards cefuroxime.
  • - Antibiotic treatment with cefuroxime 4 days prior to surgery.

研究者

发起方
Aarhus University Hospital

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