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Pressure Injury Prevention in AE and PFC

Primary Purpose

Pressure Injury, Military Activity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mepilex
LiquiCell
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pressure Injury focused on measuring Pressure injury/prevention, Military Nursing, Risk Reduction

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest

Group 2: Without Mepilex on Litter + AE mattress + backrest

Group 3: Mepilex on VSB on AE mattress

Group 4: Without Mepilex on VSB on AE mattress

Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter

Group 6: PFC Without LiquiCell on Talon Litter

Arm Description

Intervention: Mepilex

Intervention: Control (no Mepilex)

Intervention: Mepilex

Intervention: Control (no Mepilex)

Intervention: LiquiCell mat

Intervention: Control (no LiquiCell)

Outcomes

Primary Outcome Measures

Change in Interleukin-1/Total Protein (Skin)
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)
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)
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
Skin temperature will be measured continuously on the sacrum using a laser doppler probe.
Change in Skin Interface Pressure
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

Change in Pressure-Discomfort (Category Partitioning Scale-50)
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.

Full Information

First Posted
April 10, 2019
Last Updated
March 1, 2022
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03924622
Brief Title
Pressure Injury Prevention in AE and PFC
Official Title
Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Unable to continue to conduct study procedures due to pandemic
Study Start Date
July 20, 2019 (Actual)
Primary Completion Date
September 23, 2020 (Actual)
Study Completion Date
September 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury, Military Activity
Keywords
Pressure injury/prevention, Military Nursing, Risk Reduction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest
Arm Type
Experimental
Arm Description
Intervention: Mepilex
Arm Title
Group 2: Without Mepilex on Litter + AE mattress + backrest
Arm Type
No Intervention
Arm Description
Intervention: Control (no Mepilex)
Arm Title
Group 3: Mepilex on VSB on AE mattress
Arm Type
Experimental
Arm Description
Intervention: Mepilex
Arm Title
Group 4: Without Mepilex on VSB on AE mattress
Arm Type
No Intervention
Arm Description
Intervention: Control (no Mepilex)
Arm Title
Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter
Arm Type
Experimental
Arm Description
Intervention: LiquiCell mat
Arm Title
Group 6: PFC Without LiquiCell on Talon Litter
Arm Type
No Intervention
Arm Description
Intervention: Control (no LiquiCell)
Intervention Type
Device
Intervention Name(s)
Mepilex
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
LiquiCell
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Interleukin-1/Total Protein (Skin)
Description
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)
Time Frame
Baseline through study completion - approximately 120 minutes
Title
Change in Transcutaneous Tissue Oxygen (TcPO2)
Description
Tissue oxygen is measured continuously on the sacrum using a noninvasive sensor and on the midsternum (midchest) as a control
Time Frame
Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
Title
Change in Skin Moisture (Epidermal and Subepidermal)
Description
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.
Time Frame
Baseline (before lying down) and after 120 minutes supine
Title
Change in Skin Temperature
Description
Skin temperature will be measured continuously on the sacrum using a laser doppler probe.
Time Frame
Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
Title
Change in Skin Interface Pressure
Description
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.
Time Frame
Continuously during the supine phase of the study (120 minutes)
Secondary Outcome Measure Information:
Title
Change in Pressure-Discomfort (Category Partitioning Scale-50)
Description
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.
Time Frame
The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Bridges, PhD, RN
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington School of Nursing
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29606674
Citation
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.
Results Reference
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Pressure Injury Prevention in AE and PFC

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