Novel Support Surface Based on Smart Materials to Alleviate Pressure Ulcer Formation During the Rehabilitation of Immobile Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- PTAUC
研究概览
简要总结
A prototype support surface has been designed which aims to successfully redistributes the pressures exerted and provides sufficient support to human soft tissue
We want to prove the effectiveness of the prototype support surface by enlisting patients in a clinical trial, where we will assess the presence of pressure ulcers, and the ability of the patients to tolerate the support surface, and also measure the pressure over time and compare them to when the patients are using standard mattresses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be immobile as assessed on the braden scale.
- •Patients must require 2 hourly turning
排除标准
- •No existing pressure ulcers
- •No active infections, fever, or medical conditions that require constant medical attention.
- •They must also not have severe incontinence requiring the change of diapers more frequently than 4 hours
- •No significant cognitive impairment
- •Pregnant women will be excluded from the study
研究组 & 干预措施
Standard care mattress
Patient will have 2 days to familiarize with the novel support surface. Patient will be on standard care mattress. They will be turned over every 2 hours for 3 days.
干预措施: Novel support surface (Device)
Novel support surface
After the standard care mattress, the same patient will be placed on novel support surface. They will be turned over every 2 hours for 3 days.
Patient will then continue with the novel support surface and turned every 3 hours for 3 days.
They will then continue with the novel support surface and turned every 4 hours for 3 days.
干预措施: Novel support surface (Device)
结局指标
主要结局
PTAUC
时间窗: For a maximum of 14 days (duration of trial)
pressure-time area under curve
Pressure sores - NPUAP (National Pressure Ulcer Advisory Panel) grade
时间窗: For a maximum of 14 days (duration of trial)
If pressure sores are present, they will be graded based on the NPUAP grade from 1-4. Location will also be recorded.
次要结局
- Patient's comfort(For a maximum of 14 days (duration of trial))
- Discomfort or pain(For a maximum of 14 days (duration of trial))
- Suggestions(For a maximum of 14 days (duration of trial))