Novel Wound Powder RGN107 to Reduce Wound Odor, Pain and Exudate at End-of-life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- usability
研究概览
简要总结
This study will test a special powder for ulcers caused by a variety of conditions such as pressure that sometimes happen when a person is at the end of life. The powder will be applied to these ulcers to see if it helps with pain, odor and drainage (leakage). People who are being cared for by hospice or palliative care organizations will be invited to be in the study. The study will also find out if the powder is easy to use by caregivers as well as improving the comfort and quality of life of the person who has the ulcer.
详细描述
Aim 1. In a comparative 2-group design, we will evaluate and compare the feasibility of the intervention through assessment in both settings (home-based and inpatient) on:
- Adherence to RGN107 protocol by licensed care providers and/or family or other caregivers providing wound care; measures include implementation of procedures, frequency of dressing changes.
- Reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation.
- Usability issues such as powder ability to stick to wound and ease of use of applying powder.
Aim 2. Estimate variability of outcome measurements and effect sizes and investigate the presence of a preliminary "signal" of clinical efficacy in two groups of hospice/home health/residential individuals receiving RGN107 in:
- Physical wound symptoms outcomes, specifically pain, odor and exudate.
- Quality of life of individuals receiving and caregivers using RGN107.
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
- 21 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21 years or older
- •Patient prognosis > 1 month and < 6 months
- •Pressure wounds
- •Pain or odor or exudate score > 2 on VAS
- •Wound caregiver able to perform required protocol activities
排除标准
- •Known allergies to Turmeric, Mint, Sandalwood
- •Using negative pressure wound therapy
- •Currently using topical creams or ointments applied to wound bed (powder will not adhere to these products)
- •Wound with eschar covering (powder will not stick)
结局指标
主要结局
usability
时间窗: 4 weeks
usability issues such as powder ability to stick to wound and ease of use of applying powder.
adherence
时间窗: 4 weeks
adherence to RGN107 protocol by licensed care providers and/or family or other caregivers providing wound care; measures include implementation of procedures, frequency of dressing changes.
reach
时间窗: 4 weeks
reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation.
次要结局
- symptoms(4 weeks)
- quality of life(4 weeks)
研究者
Teresa Kelechi
Professor
Medical University of South Carolina