A Study to Evaluate the HS Specific Wound Dressing HidraWear AX in the Home Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Ease of Use Day 21 vs Day 0
研究概览
简要总结
The product, HidraWear AX (www.hidrawear.com) is and adhesive free wound dressing system for the every day home care of Hidradenitis Suppurativa (HS), a debilitating disease of the skin for which there are limited wound dressing products.
This is a study to assess the use HidraWear Ax vs current product and method of use, and to determine the impact on patients' quality of life.
详细描述
The objective is to evaluate the ease of use of Hidrawear AX compared to the subject's existing product use in 23 subjects with HS (Hidradenitis Suppurativa).
Secondary objectives are to evaluate if Hidrawear AX:
- Is comfortable
- Improves quality of life
- Faster to use than the subject's existing product
- Reduces dressing related pain
- Secure dressing retention
This pilot study will evaluate usability - the safety, efficacy and performance of HidraWear AX in the home setting. Quality of life, ease of use and comfort of Hidrawear AX will be assessed.
The clinical effect of the wound pad will not be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form in English.
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Female, aged >18
- •Diagnosed with Hidradenitis Suppurativa
- •Hidradenitis Suppurativa affecting the axilla
- •Exuding lesion that requires wound dressings
排除标准
- •Recent surgery <3 months in axilla
- •Psoriasis, Dermatitis or skin conditions/rash other than Hidradenitis Suppurativa on or near affected area
- •Pregnancy or lactation
- •Known allergic reactions to components of Hidrawear AX
结局指标
主要结局
Ease of Use Day 21 vs Day 0
时间窗: 3 weeks
10 point visual analogue scale with a maximum score of 10 and a minimum score of 0. self reported . A score of 0 means the product is very easy to use, and a score of 10 means the product is very difficult to use. A lower score represents a better outcome.
次要结局
- Change in Quality of Life (QoL) Measured Using the Dermatology Life Quality Index (DLQI)(3 weeks)
- Visual Pain Analogue Scale Day 21 vs Day 0(3 weeks)
- Time Taken to Dress Wounds(3 weeks)
- Body Image Visual Analogue Scale(3 weeks)
- Patient Comfort(3 weeks)
- Confidence in Dressing Product (Secure Retention, Leak Reduction)(3 weeks)