Team LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa and Other Low Resource Settings.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Skin Irritation as Measured by Draize Score for Erythema and Edema
研究概览
简要总结
The purpose of this study is to examine the safety of the LowCostomy appliance's peristomal adhesive interface composed of a mix of beeswax and pine resin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Healthy adults with age +/>18 years
- •Recruited from Duke University
- •Local community members
排除标准
- •Any pre-existing skin conditions
- •Skin allergies to tegaderm or other adhesive products contained within the study and control rings
结局指标
主要结局
Skin Irritation as Measured by Draize Score for Erythema and Edema
时间窗: Assessed daily up to 7 days, day 7 reported
The Draize score (for each erythema and edema) has a range of 0 to 4, where a higher score indicated greater irritation. Individual scores below 3 were classified as not severe.
Skin Irritation as Measured by the 5-D (5-dimension) Itch Scale
时间窗: Assessed daily up to 7 days, day 7 reported
The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the itching. The score ranges from 5 to 25, where a higher score indicates greater itching.
Skin Irritation as Measured by Survey: "During the Last Week, How Many Hours a Day Have You Been Itching?"
时间窗: Assessed daily up to 7 days, day 7 reported
Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks"
时间窗: Assessed daily up to 14 days, day 14 reported
Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?"
时间窗: Assessed daily up to 7 days, day 7 reported
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on SLEEP Over the Last Week"
时间窗: Assessed daily up to 7 days, day 7 reported
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week"
时间窗: Assessed daily up to 7 days, day 7 reported
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week"
时间窗: Assessed daily up to 7 days, day 7 reported
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week"
时间窗: Assessed daily up to 7 days, day 7 reported
Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body"
时间窗: Assessed daily up to 7 days, day 7 reported
次要结局
- Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection(Assessed daily up to 7 days, day 7 reported)
- Overall Well-being as Measured by Daily Survey(Daily, days 1-7)