NCT04648631已完成不适用
The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Microbiome
研究概览
简要总结
The purpose of this study is to look at the change in the microbiome (bacterial composition) of an HS tunneling wound and examine if treatment with an antibiofilm surfactant wound gel (ABWG) (a topical medication that will fight bacteria attached to the surface of those tunnels) changes the bacterial composition of the wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years old and older
- •Have diagnosis of HS confirmed by a dermatologist
- •Have at least one HS related tunneling wound that is at least 2 centimeters in length
- •Able to provide informed consent
排除标准
- •Individuals who are not yet adults
- •Women known to be pregnant
- •Subjects, who in the opinion of the PI, cannot comply with home application of the treatment.
结局指标
主要结局
Change in Microbiome
时间窗: Baseline, 4 weeks
As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.
次要结局
- Change in Lesion Severity as Measured by HS-PGA(Baseline, 4 week)
- Change in Lesion Severity as Measured by the Hurley Stage(Baseline, 4 weeks)
- Change in Pain as Measured by VAS(Baseline, 4 weeks)
- Change HS Lesion Erythema(Baseline, 4 weeks)
- Number of Participants With Decreased Pain Medication Use(4 weeks)
- Change in Number of Days of Work/School Lost(Baseline, 4 weeks)
- Change in Range of Motion(Baseline, 4 weeks)
- Number of Dressings Used(4 weeks)
- Number of Participants With Escalated Pain Medication Use(4 weeks)
- Change in Exudate(Baseline, 4 weeks)
- Change in Quality of Life as Measured by HiSQOL(Baseline, 4 weeks)
- Change in Quality of Life as Measured by DLQI(Baseline, 4 weeks)
研究者
Hadar Lev-Tov
Assistant Professor
University of Miami
研究点 (2)
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