Sacral Savers: Study of Prevention and Enhanced Healing of Sacral and Trochenteric Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Bubble wrap mattress for Pressure Ulcer prevention, measured by a ruler (cm)
研究概览
简要总结
The purpose of the study is to investigate the ability of the product "Sacral Saver," to prevent and /or help healing bed sores.
详细描述
The purpose of this research study is to investigate the ability of the product "Sacral Savers." to prevent and/or help healing of bed sores, in patients in health care facilities.
The Sacral saver device consists of a sheet of strong bubble-wrap-like material, folded at one end and covered by a nylon sham with a pocket in which the bubble wrap is placed. The assembled device is placed under the bed sheet in such a way that the small of the back rests on the fold. This will lift the back and reduce the pressure of the buttocks on the bed. When lying on the side, it will reduce the pressure on the hip.
Participants are being asked to participate in this study because you are at risk for, or already have a bedsore on the buttocks or the hip.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient who is immobilized for prolonged periods, either in acute care, or chronic care situations.
- •All patients with: paralysis, quadriplegia, paraplegia, trauma patients, requiring prolonged immobilization, patients on ventilators.
- •All patients with pre-existing pressure ulcers in the lower back and or hip regions.
排除标准
- •There are no age, gender or co-morbidity exclusions
研究组 & 干预措施
Standard Care of Treatment
Participants will be treated with standard of care treatment.
干预措施: Standard Care of Treatment (Other)
SacralSaver
SacralSaver
干预措施: SacralSaver (Device)
结局指标
主要结局
Bubble wrap mattress for Pressure Ulcer prevention, measured by a ruler (cm)
时间窗: 6 weeks
This pilot study of 30 participants (15 control, 15 experimental) will test the safety and efficacy of using a bubble wrap mattress for pressure ulcer. Participants in one group would receive standard of care treatment and the other group would receive the intervention of the bubble wrap mattress. Participants would be followed for 6 weeks to assess wound healing and tolerance of the treatment. of ulcers. The outcome measure will measure 30 participants, 15 treated with the SacralSavers device and 15 participants with standard of care treatment up to the resolution of the participant's ulcer.
次要结局
未报告次要终点