Air Fluidized Therapy Use in Patients Who Present With Suspected Deep Tissue Injury - a Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Degree of breakdown
研究概览
简要总结
Patients with a suspected Deep Tissue Injury (or a purple reddened area over a bony prominence of their body, which is expected to break down into a pressure ulcer) will be place on the Clinitron® Rite HiteTM bed to see if the air fluidized mattress decreases the amount of tissue breakdown from their bruise.
详细描述
Up to 15 centers will participate in this case series in acute care and long term acute care facilities. Patients who present with sDTI and consent for study will have the Clinitron® Rite HiteTM bed ordered and delivered within a 12 hour window to be able to participate. They will have their sDTI photographed, and an assessment of expected breakdown will be noted by the clinical team. The patient will be followed during the course of hospitalization and additional photographs and documentation will be performed by the clinical team to demonstrate the actual breakdown that occurred.
Information including the pertinent history of current illness, co-morbid conditions, and demographic information will be shared with the sponsor in order to demonstrate each case.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with sDTI on the supine aspect of their body
- •Patient does not require a pulmonary specialty bed for care
- •Patient is expected to be in the hospital for at least 3 days
- •Patient weighs between 30 and 350 Lbs.
- •Patient's height is less than 75 inches tall
- •Patient, or patient's representative, is willing and able to sign written informed consent
- •Patient is expected to survive hospitalization.
排除标准
- •Patient is less than 18 years of age
- •Patient has already participated in this study
结局指标
主要结局
Degree of breakdown
时间窗: 21 days
This case series seeks to identify patients with suspected DTI and capture actual patient outcomes with AFT treatment
次要结局
未报告次要终点