跳至主要内容
临床试验/NCT02662101
NCT02662101已完成不适用

Molecular Microbial Ecology as a Diagnostic Tool to Identify Mode of Action and New Targets for Oxidized Silver Wound Dressings

Exciton Technologies Inc.0 个研究点目标入组 17 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
主要终点
Observe microbes in the wound

研究概览

简要总结

Chronic non-healing wounds considerably impact quality of life in affected patients and are a substantial burden on the Canadian health care system. Microbes colonizing a chronic wound play an important role in impeding effective healing. Chronic wounds are colonized by polymicrobial communities and no single organism can be seen as causal. Only a small fraction of wound bacteria are cultured by diagnostic tests and studies have shown little agreement between culture and molecular based approaches, therefore an effective diagnostic for wound microbes is required. It is know that the composition of the microbial community associated with a wound changes as it heals although the causal relationship is somewhat unclear. Although not very effective in treating chronic non-healing wounds, antibiotics are often administered, contributing to concerns of antibiotic resistance. The wound dressings produced by Exciton Technologies Inc. (ETI) effectively aid in the healing process in chronic wounds through unknown mechanisms. ETI's wound dressings contain a combination of silver salts with three different valence, +1, +2 and +3 that have antimicrobial activity and are effective in reducing biofilm formation in vitro. However, it is not known how these silver salts impact microbial ecology of the wound and the role this plays in wound healing. The objectives of this research are to develop a new diagnostic tool based on molecular characterization of wound sites so as to predict how to best treat wounds and to identify new microbes to be targeted by ETI's technology. This project will utilize molecular microbial ecology for the assessment and evaluation of topical silver interventions, gaining insight into the management of chronic infection. Substantiating the microbiota-modifying effectiveness of silver wound dressings towards increasing clinician and patient understanding to improving clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
17 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed or verbal informed consent
  • >17 yrs and <70 yrs of age
  • have a chronic wound (defined as >6 weeks, non-healing), with or without clinical signs of infection.
  • requires visitation or admittance to the clinic and subsequent visits for dressing changes

排除标准

  • Systemic antibiotics within the last 2 weeks.
  • known skin sensitivity to any of the dressing components
  • Poor prognosis and who are unlikely to survive the trial period.
  • Participating in another concurrent trial.
  • Exhibiting any other medical condition, which, according to the investigator, justifies the subject's exclusion from the trial.

结局指标

主要结局

Observe microbes in the wound

时间窗: 4 weeks

The primary outcome variable will be the observations to changes in the composition of microbes after the application of the wound dressing.

次要结局

  • Observe wound progression(4 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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