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出境医 / 临床实验 / Pressure Injury Prevention in AE and PFC

Pressure Injury Prevention in AE and PFC

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pressure Injury Military Activity Device: Mepilex Device: LiquiCell Not Applicable

Detailed Description:
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Stratified randomized control trial with subjects assigned to either the simulated aeromedical evacuation (standard mattress or vacuum spine board) or Prolonged Field Care arms with or without the intervention. Stratification will be based on body fat percentage. Study does not involve FDA-regulated drug.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care
Actual Study Start Date : July 20, 2019
Actual Primary Completion Date : September 23, 2020
Actual Study Completion Date : September 23, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest
Intervention: Mepilex
 Device: Mepilex
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.
No Intervention: Group 2: Without Mepilex on Litter + AE mattress + backrest
Intervention: Control (no Mepilex)
Experimental: Group 3: Mepilex on VSB on AE mattress
Intervention: Mepilex
 Device: Mepilex
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.
No Intervention: Group 4: Without Mepilex on VSB on AE mattress
Intervention: Control (no Mepilex)
Experimental: Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter
Intervention: LiquiCell mat
 Device: LiquiCell
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.
No Intervention: Group 6: PFC Without LiquiCell on Talon Litter
Intervention: Control (no LiquiCell)
Outcome Measures
Primary Outcome Measures :
  1. Change in Interleukin-1/Total Protein (skin) [ Time Frame: 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)

  2. Change in Transcutaneous tissue oxygen (TcPO2) [ Time Frame: 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

  3. Change in Skin Moisture (epidermal and subepidermal) [ Time Frame: 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.

  4. Change in Skin Temperature [ Time Frame: 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.

  5. Change in Skin interface pressure [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Pressure-Discomfort (Category Partitioning Scale-50) [ Time Frame: The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements). ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
United States, Washington
University of Washington School of Nursing
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Bridges, PhD, RN University of Washington
Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE July 20, 2019
Actual Primary Completion Date September 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Change in Interleukin-1/Total Protein (skin) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019) 		Change in Pressure-Discomfort (Category Partitioning Scale-50) [ Time Frame: The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements). ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pressure Injury Prevention in AE and PFC
Official Title  ICMJE Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Stratified randomized control trial with subjects assigned to either the simulated aeromedical evacuation (standard mattress or vacuum spine board) or Prolonged Field Care arms with or without the intervention. Stratification will be based on body fat percentage. Study does not involve FDA-regulated drug.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Pressure Injury
  • Military Activity
Intervention  ICMJE
  • Device: Mepilex
    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.
  • Device: LiquiCell
    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.
Study Arms  ICMJE
  • Experimental: Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest
    Intervention: Mepilex
    Intervention: Device: Mepilex
  • No Intervention: Group 2: Without Mepilex on Litter + AE mattress + backrest
    Intervention: Control (no Mepilex)
  • Experimental: Group 3: Mepilex on VSB on AE mattress
    Intervention: Mepilex
    Intervention: Device: Mepilex
  • No Intervention: Group 4: Without Mepilex on VSB on AE mattress
    Intervention: Control (no Mepilex)
  • Experimental: Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter
    Intervention: LiquiCell mat
    Intervention: Device: LiquiCell
  • No Intervention: Group 6: PFC Without LiquiCell on Talon Litter
    Intervention: Control (no LiquiCell)
Publications * Bridges E, Whitney JD, Burr R, Tolentino E. Reducing the Risk for Pressure Injury During Combat Evacuation. Crit Care Nurse. 2018 Apr;38(2):38-45. doi: 10.4037/ccn2018223.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 2, 2020) 		54
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2019) 		72
Actual Study Completion Date  ICMJE September 23, 2020
Actual Primary Completion Date September 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03924622
Other Study ID Numbers  ICMJE STUDY00006022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elizabeth Bridges, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizabeth Bridges, PhD, RN University of Washington
PRS Account University of Washington
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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