A Prospective Randomised Controlled Trial of the Effectiveness of Absorbent Silicone Self Adherent Dressings in the Prevention of Sacral and Heel Pressure Ulcers in Trauma and Critically Ill ED/ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Pressure ulcer incidence
研究概览
简要总结
The study is designed as a randomised controlled trial of trauma patients admitted to the Royal Melbourne Hospital (RMH) Emergency Department (ED) and subsequently transferred to the Intensive Care Unit (ICU). Patients meeting the study inclusion criteria will be randomly allocated to either the control group that will receive usual pressure ulcer prevention strategies or the trial group that will receive usual care plus have a Mepilex Border Sacrum dressing applied to their sacrum and Mepilex Boarder Heel dressing applied to each heel in the ED.
Hypothesis:Patients treated with Mepilex Border dressings will have a lower incidence rate of sacral and heel pressure ulcer development than patients receiving standard care.
详细描述
Aims
To determine the effectiveness of Mepilex Border dressings in preventing sacral and heel pressure ulcer development
To determine the cost effectiveness of Mepilex Border dressings in preventing sacral and heel pressure ulcers.
Primary endpoint
Incidence rates of pressure ulcers in ICU expressed as the total number of pressure ulcers developed per week in both groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •ED and ICU admission for critical illness and/or major trauma Over 18 years old
排除标准
- •Less than 18 years old Suspected or actual spinal injury Pre-existing sacral or heel pressure ulcer Trauma to sacral and/or heel area
结局指标
主要结局
Pressure ulcer incidence
时间窗: Weekly
Number of pressure ulcers developed in the ICU per week
次要结局
- Cost(Weekly)