跳至主要内容
临床试验/NCT06460025
NCT06460025进行中(未招募)不适用

Slough in Acute or Chronic Wounds for the Diagnosis of Microbiology Cultivation

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
131
试验地点
1
主要终点
cohen's k coefficient of Gram Stain between Slough and Swap Specimens

研究概览

简要总结

Slough was a visible indicator of biofilm, which was the most available specimen from acute and chronic wounds. However, studies believed that slough were poorly accurate, and that the Levine swab was more recommended for sampling bacterial culture. This study aimed to compare slough with swab sample and analyze the consistency.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with acute and chronic wounds who were first seen at the Wound Care Centre of Peking University Third Hospital from October 2022 to October 2023;
  • Patients who have followed the wound sample collection SOP to simultaneously take wound swabs and putrefactive samples and send them for bacterial culture;;
  • Patients aged 18 years or older;

排除标准

  • Patients who had been taken only one of the wound samples, either swab or slough;
  • The swab collection did not meet the deifinitions for the exudate method or the Levine technique;
  • Bacterial culture profile was incomplete didn't meet the requirement of the trial.

结局指标

主要结局

cohen's k coefficient of Gram Stain between Slough and Swap Specimens

时间窗: Day 0, patients' the first site in wound healing center

compare the difference of Gram Stain after bacterial culture between Slough and Swap Specimens, by using statistics of cohen's k coefficient,values of κ from The κ coefficients in 0.81 to 1 waeres interpreted as excellentalmost perfect concordance, with 0.61 to 0.80 asrepresented substantial, 0.41 to 0.60 as mean moderate, 0.21 to 0.40 as fair, and 0 to 0.20 as slight.

次要结局

  • cohen's k coefficient of Common pathogens between Slough and Swap Specimens(Day 0, patients' the first site in wound healing center)
  • agreements in microbiology cultivation between slough and swap(Day 0, patients' the first site in wound healing center)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Long Zhang

Professor, Head of Wound Healing Center

Peking University Third Hospital

研究点 (1)

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