Pressure Injury Prevention in AE and PFC
2022年3月1日 更新者：Elizabeth Bridges、University of Washington
Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
72
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Washington
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Seattle、Washington、美国、98195
- University of Washington School of Nursing
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria
- Previous injuries to sacrum/buttocks with scarring
- History of pressure injuries
- Cardiovascular disease
- Neurological disease that would affect vascular response
- Diabetes
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest
Intervention: Mepilex
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Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries.
The dressing will be placed on the sacrum.
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无干预：Group 2: Without Mepilex on Litter + AE mattress + backrest
Intervention: Control (no Mepilex)
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实验性的：Group 3: Mepilex on VSB on AE mattress
Intervention: Mepilex
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Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries.
The dressing will be placed on the sacrum.
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无干预：Group 4: Without Mepilex on VSB on AE mattress
Intervention: Control (no Mepilex)
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实验性的：Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter
Intervention: LiquiCell mat
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LiquiCell is a thin layer of low-viscosity fluid contained in a series of bursa-like pouches.
Baffles within each pouch channel the liquid to disperse pressure and the volume of liquid in the pouch is so small that there is no pressure-build up.
LiquiCell is available commercially as a 36 X 18-inch mattress overlay (LiquiCell Shear Reducing Mattress Overlay) with a soft pliable top and a non-slip bottom.
The overlay is positioned from the shoulders to below the hips to minimize shear.
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无干预：Group 6: PFC Without LiquiCell on Talon Litter
Intervention: Control (no LiquiCell)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Interleukin-1/Total Protein (Skin)
大体时间：Baseline through study completion - approximately 120 minutes
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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)
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Baseline through study completion - approximately 120 minutes
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Change in Transcutaneous Tissue Oxygen (TcPO2)
大体时间：Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Tissue oxygen is measured continuously on the sacrum using a noninvasive sensor and on the midsternum (midchest) as a control
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Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Change in Skin Moisture (Epidermal and Subepidermal)
大体时间：Baseline (before lying down) and after 120 minutes supine
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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.
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Baseline (before lying down) and after 120 minutes supine
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Change in Skin Temperature
大体时间：Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Skin temperature will be measured continuously on the sacrum using a laser doppler probe.
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Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Change in Skin Interface Pressure
大体时间：Continuously during the supine phase of the study (120 minutes)
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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.
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Continuously during the supine phase of the study (120 minutes)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Pressure-Discomfort (Category Partitioning Scale-50)
大体时间：The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).
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This scale asks the participant to describe in verbal terms the pressure intensity or discomfort associated with the stimulus (i.e., sacral/buttocks pressure or discomfort).
The participant can then fine tune their assessment using a numeric score.
The final score is an analog.
The score ranges from 0-52, with higher scores indicating higher pressure or more severe discomfort.
The investigator will ask the participant to limit their evaluation to the pressure/discomfort sensed on the sacrum/buttocks, but the investigator will also ask the participants to identify on their body where they are experiencing the most pressure/discomfort.
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The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Elizabeth Bridges, PhD, RN、University of Washington
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年7月20日
初级完成 (实际的)
2020年9月23日
研究完成 (实际的)
2020年9月23日
研究注册日期
首次提交
2019年4月10日
首先提交符合 QC 标准的
2019年4月19日
首次发布 (实际的)
2019年4月23日
研究记录更新
最后更新发布 (实际的)
2022年5月16日
上次提交的符合 QC 标准的更新
2022年3月1日
最后验证
2022年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Mepilex的临床试验
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Molnlycke Health Care AB终止
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Birken AG完全的