跳至主要内容
临床试验/NCT06679023
NCT06679023进行中(未招募)不适用

Biofilms in Chronic Wounds Pathogenesis and Diagnosis: Quantification of Biofilm and Validation of Grading System in Modified Alcian Blue Biofilm Detection Kit (WBDK-GB)

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月17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
60
试验地点
1
主要终点
90-day wound healing

研究概览

简要总结

Chronic wound is a leading health issue in current health care system. Biofilm is a notorious risk factor of unhealed wound. Although biofilm-direct wound care has been a prevalent strategy of wound care currently, diagnosis of biofilm still remained as an unmet clinical need. Several advanced diagnostic tools of biofilm had been published in recent years, however, the evidence was still insufficient.

In this study, we will enroll patients with chronic wounds, collect the wound debris, quantify the biofilm and validate with the signals of advanced diagnostic tools for biofilm detection, hoping to transform the tools which could only tell us whether the biofilm is present or not, into the severity of biofilm infection. The two tested tools includes of MolecuLight i:X and wound blotting and Alcian blue biofilm detection kit.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 1.Age 18 or older
  • 2.Has an unhealed wound and is scheduled for debridement surgery
  • 3.Patients who are receiving wound care at this hospital (Hsinchu branch) and are able to comply with follow-up wound monitoring

排除标准

  • Does not consent to provide remaining tissue from wound treatment for in vitro analysis.
  • Allergic to nylon components.
  • Under 18 years of age.

结局指标

主要结局

90-day wound healing

时间窗: 90 days

observation 90-day wound healing and its relationship with clinical data and biofilm severity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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