RCT on Wheeled Mobility for Preventing Pressure Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- Incidence of a Sitting-induced Pressure Ulcer
研究概览
简要总结
The proposed clinical trial is aimed at demonstrating the important role wheelchairs play in preventing pressure ulcers (bed sores). Although most pressure ulcers can be prevented, they are common in nursing home settings because their causes are difficult to identify. This clinical trial will guide practitioners toward improving preventive care practices by demonstrating how to effectively apply wheelchair and seat cushion technology.
详细描述
Pressure ulcers are a significant healthcare problem for the growing number of nursing home residents in the United States and around the world. Pressure ulcers diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare costs. Costs for the management of pressure ulcers in the US likely exceeds $6.4 billion annually, with a prevalence of approximately 12% in the high risk LTC population. A previous clinical trial at the University of Pittsburgh studied the effects of seat cushions on pressure ulcer incidence and found that when a skin protection seat cushion is used with a properly fitted wheelchair there is a significant reduction in incidence. The data led the investigators to question whether having a properly fitted wheelchair also has a significant effect on pressure ulcer incidence. This clinical trial investigate this question by randomizing subjects into a control group that receives a skin protection cushion and wheelchair training for use in their facility supplied wheelchair, or a treatment group that receives a skin protection cushion, wheelchair training and a new custom-fitted wheelchair. We expect that the treatment group will have a lower incidence of pressure ulcers.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female nursing home resident 60 years of age and older
- •A Braden score of less than or equal to 18
- •A combined Braden Activity and Mobility Subscale score less than or equal to 5
- •Absence of ischial and sacral area pressure ulcers (see definition of pressure ulcer)
- •A tolerance for total daily wheelchair sitting time of greater than or equal to 6 hours (not continuous)
- •Ability to accommodate seating and positioning needs with the wheelchair selected for use in this study (Breezy Ultra 4)
- •Informed written consent
排除标准
- •Body weight exceeding 250 lbs.
- •Hip width exceeding 20 in.
- •Wheelchair seating requirements for additional head support, seat depth > 20 inches, elevated leg rests or severe orthopedic deformities of the pelvis, lower extremities or back that exceed the accommodating capability of the Breezy Ultra 4 wheelchair.
- •Current use of any cushioning material(s) other than a standard cushion, a folded pad, or a pillow (standard cushion as defined by HCPCS code for Standard Cushions, i.e., non-skin protection cushion)
- •Current use of a HCPCS code K0004 wheelchair
结局指标
主要结局
Incidence of a Sitting-induced Pressure Ulcer
时间窗: 182 days
Skin assessments for incidence of sitting-induced pressure ulcers will occur once per week until the occurrence of a pressure ulcer or 182 days
次要结局
未报告次要终点
研究者
David Brienza
Professor
University of Pittsburgh