Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Interleukin-1/Total Protein (Skin)
研究概览
简要总结
This study evaluates the effect of a multilayer skin dressing (Mepilex) placed on the sacrum or a fluid filled pad (LiquiCell) on risk factors for pressure injuries under conditions consistent with military long-distance transport or prolonged field care. Participants will be assigned to one of six groups - air transport, air transport on a spinal immobilization surface with or without Mepilex or on a field stretcher with or without LiquiCell.
详细描述
Combat casualties undergoing long distance aeromedical evacuation (AE), particularly casualties who are immobilized because of possible spine injuries, and casualties who required prolonged field care are at increased risk for pressure injuries. The risk factors pressure and shear are potentially modifiable via solutions appropriate for these austere conditions. Two interventions (Mepilex and LiquiCell) will be evaluated under conditions simulating military medical transport on a standard stretcher or with spinal immobilization in a vacuum spine board (VSB) or on a military stretcher used under field conditions. Mepilex is a multi-layer dressing that can be placed on the skin (sacrum/buttocks) and LiquiCell is a pad filled with pockets of fluid that is placed under the back and buttocks. The effect of these interventions compared to not using them will be studied under the three conditions with or without the intervention (Mepilex or LiquiCell) using measures obtained on the lower back/sacrum including skin interface pressure, oxygen, moisture, and temperature and a cytokine indicating possible tissue damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Age 18 to 55
- •Meet the physical standards for military personnel
- •Weigh less than 250 pounds
- •Be able to remain in the study position for the duration of the study.
排除标准
- •Previous injuries to sacrum/buttocks with scarring
- •History of pressure injuries
- •Cardiovascular disease
- •Neurological disease that would affect vascular response
- •History of malignancy
- •Current skin condition (e.g., eczema or psoriasis)
- •Current neck/back pain or history of chronic neck/back pain
- •Known vertebral/spinal cord disease/injury (scoliosis, kyphosis, or lordosis)
- •Self-reported pregnancy
- •Concern about ability to remain in the vacuum spine board for 120 minutes
研究组 & 干预措施
Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest
Intervention: Mepilex
干预措施: Mepilex (Device)
Group 2: Without Mepilex on Litter + AE mattress + backrest
Intervention: Control (no Mepilex)
Group 3: Mepilex on VSB on AE mattress
Intervention: Mepilex
干预措施: Mepilex (Device)
Group 4: Without Mepilex on VSB on AE mattress
Intervention: Control (no Mepilex)
Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter
Intervention: LiquiCell mat
干预措施: LiquiCell (Device)
Group 6: PFC Without LiquiCell on Talon Litter
Intervention: Control (no LiquiCell)
结局指标
主要结局
Change in Interleukin-1/Total Protein (Skin)
时间窗: Baseline through study completion - approximately 120 minutes
Skin cytokine (IL-1) and total protein will be obtained using a small strip of specialized tape placed on the sacrum/buttocks. After 1-minute application the tape is removed and analyzed for quantity of interleukin-1 (indicator of skin irritation)
Change in Transcutaneous Tissue Oxygen (TcPO2)
时间窗: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
Tissue oxygen is measured continuously on the sacrum using a noninvasive sensor and on the midsternum (midchest) as a control
Change in Skin Moisture (Epidermal and Subepidermal)
时间窗: Baseline (before lying down) and after 120 minutes supine
Two components of skin moisture will be measured on the sacrum using the Delfin MoistureMeter. The epidermal moisture, which reflects perspiration and subepidermal moisture , which reflects water content of the tissues. The values range from 1-80, with higher numbers reflecting increased moisture.
Change in Skin Temperature
时间窗: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
Skin temperature will be measured continuously on the sacrum using a laser doppler probe.
Change in Skin Interface Pressure
时间窗: Continuously during the supine phase of the study (120 minutes)
The pressure between the support surface and the skin will be measured continuously during the supine position using the X Sensor system. This system measures force/unit area (e.g., pressure). The peak and average pressure on the sacrum/buttocks will be measured.
次要结局
- Change in Pressure-Discomfort (Category Partitioning Scale-50)(The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).)
研究者
Elizabeth Bridges
Professor, School of Nursing: Dept: Biobehavioral Nursing and Health Informatics
University of Washington