Military Activity, Pressure Injury
Conditions
Keywords
Pressure injury/prevention, Military Nursing, Risk Reduction
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.
Interventions
DEVICEMepilex
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.
DEVICELiquiCell
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.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interleukin-1/Total Protein (Skin) | 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) | 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) | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest Intervention: Mepilex Study surface Litter + WELP mattress pad with 30 degree backrest.
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. | 10 |
| Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest Intervention: Control (no Mepilex)
Study surface Litter + WELP mattress pad with 30 degree backrest. No Mepilex | 9 |
| Group 3: Mepilex on VSB on WELP Mattress Intervention: Mepilex Litter + WELP mattress + Vacuum Spineboard.
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. | 9 |
| Group 4: Without Mepilex on VSB on WELP Mattress Intervention: Control (no Mepilex)
Litter + WELP mattress + Vacuum Spineboard. No Mepilex | 8 |
| Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter Intervention: LiquiCell mat Talon litter 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. | 9 |
| Group 6: PFC Without LiquiCell on Talon Litter Intervention: Control (no LiquiCell)
Talon litter | 9 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Study closed due to pandemic with approval of funding agency/IRB | 2 | 3 | 3 | 4 | 3 | 3 |
Baseline characteristics
| Characteristic | Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest | Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest | Group 3: Mepilex on VSB on WELP Mattress | Group 4: Without Mepilex on VSB on WELP Mattress | Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter | Group 6: PFC Without LiquiCell on Talon Litter | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 29.0 years STANDARD_DEVIATION 10.6 | 26.7 years STANDARD_DEVIATION 7.3 | 25.3 years STANDARD_DEVIATION 12.3 | 24.8 years STANDARD_DEVIATION 5.9 | 23.9 years STANDARD_DEVIATION 8.8 | 25 years STANDARD_DEVIATION 8 | 29 years STANDARD_DEVIATION 12 |
| Body Fat Percent | 29 Percent body fat STANDARD_DEVIATION 10.6 | 26.7 Percent body fat STANDARD_DEVIATION 7.3 | 25.3 Percent body fat STANDARD_DEVIATION 12.3 | 24.8 Percent body fat STANDARD_DEVIATION 5.9 | 23.9 Percent body fat STANDARD_DEVIATION 8.8 | 25.0 Percent body fat STANDARD_DEVIATION 8 | 25.8 Percent body fat STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 8 Participants | 9 Participants | 8 Participants | 9 Participants | 9 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 4 Participants | 26 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 6 Participants | 3 Participants | 3 Participants | 2 Participants | 5 Participants | 5 Participants | 24 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 40 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 9 | 0 / 9 |
Outcome results
Primary
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)
Time frame: Baseline through study completion - approximately 120 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest | Change in Interleukin-1/Total Protein (Skin) | -1.9 Ratio | Standard Error 2.7 |
| Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest | Change in Interleukin-1/Total Protein (Skin) | -0.8 Ratio | Standard Error 2.7 |
| Group 3: Mepilex on VSB on WELP Mattress | Change in Interleukin-1/Total Protein (Skin) | 0.13 Ratio | Standard Error 2.4 |
| Group 4: Without Mepilex on VSB on WELP Mattress | Change in Interleukin-1/Total Protein (Skin) | -4 Ratio | Standard Error 2.2 |
| Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter | Change in Interleukin-1/Total Protein (Skin) | -3.5 Ratio | Standard Error 2.7 |
| Group 6: PFC Without LiquiCell on Talon Litter | Change in Interleukin-1/Total Protein (Skin) | 0.14 Ratio | Standard Error 0.3 |
Primary
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.
Time frame: Continuously during the supine phase of the study (120 minutes)
Population: All participants exposed to the condition
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest | Change in Skin Interface Pressure | 46 mm Hg | Standard Deviation 8 |
| Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest | Change in Skin Interface Pressure | 52 mm Hg | Standard Deviation 10 |
| Group 3: Mepilex on VSB on WELP Mattress | Change in Skin Interface Pressure | 52 mm Hg | Standard Deviation 10 |
| Group 4: Without Mepilex on VSB on WELP Mattress | Change in Skin Interface Pressure | 66 mm Hg | Standard Deviation 22 |
| Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter | Change in Skin Interface Pressure | 66 mm Hg | Standard Deviation 27 |
| Group 6: PFC Without LiquiCell on Talon Litter | Change in Skin Interface Pressure | 78 mm Hg | Standard Deviation 47 |
Primary
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.
Time frame: Baseline (before lying down) and after 120 minutes supine
Population: All participants exposed to the condition
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest | Change in Skin Moisture (Epidermal and Subepidermal) | 1.5 Tissue Dielectric Constant (TDC) | Standard Deviation 2 |
| Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest | Change in Skin Moisture (Epidermal and Subepidermal) | 2 Tissue Dielectric Constant (TDC) | Standard Deviation 3.8 |
| Group 3: Mepilex on VSB on WELP Mattress | Change in Skin Moisture (Epidermal and Subepidermal) | 1.1 Tissue Dielectric Constant (TDC) | Standard Deviation 2.2 |
| Group 4: Without Mepilex on VSB on WELP Mattress | Change in Skin Moisture (Epidermal and Subepidermal) | 2.1 Tissue Dielectric Constant (TDC) | Standard Deviation 2.8 |
| Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter | Change in Skin Moisture (Epidermal and Subepidermal) | -0.1 Tissue Dielectric Constant (TDC) | Standard Deviation 2 |
| Group 6: PFC Without LiquiCell on Talon Litter | Change in Skin Moisture (Epidermal and Subepidermal) | 0.1 Tissue Dielectric Constant (TDC) | Standard Deviation 1.3 |
Primary
Change in Skin Temperature
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
Population: All participants exposed to the condition
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest | Change in Skin Temperature | 3.8 Degrees centigrade | Standard Deviation 1.3 |
| Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest | Change in Skin Temperature | 3.1 Degrees centigrade | Standard Deviation 1 |
| Group 3: Mepilex on VSB on WELP Mattress | Change in Skin Temperature | 3.7 Degrees centigrade | Standard Deviation 0.8 |
| Group 4: Without Mepilex on VSB on WELP Mattress | Change in Skin Temperature | 3.2 Degrees centigrade | Standard Deviation 1 |
| Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter | Change in Skin Temperature | 2 Degrees centigrade | Standard Deviation 2 |
| Group 6: PFC Without LiquiCell on Talon Litter | Change in Skin Temperature | 1.1 Degrees centigrade | Standard Deviation 0.9 |
Primary
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
Time frame: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
Population: All subjects exposed to condition. Data collection stopped at 60 minutes due to critically low TcPO2 - Group 2 (n = 1); Group 5 (n = 5), Group 6 (n =5). One subject (Group 6) all data collection stopped at 90 minutes due to general discomfort. Complete data analysis for all subjects through 60 minutes. Complete (120 minutes of data available Gp 1 = 10; Gp 2 = 8, Gp 3 = 9; Gp 4 = 8; Gp 5 = 4; Gp 6 = 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest | Change in Transcutaneous Tissue Oxygen (TcPO2) | -15 mm Hg | Standard Deviation 26 |
| Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest | Change in Transcutaneous Tissue Oxygen (TcPO2) | -25 mm Hg | Standard Deviation 25 |
| Group 3: Mepilex on VSB on WELP Mattress | Change in Transcutaneous Tissue Oxygen (TcPO2) | -4 mm Hg | Standard Deviation 23 |
| Group 4: Without Mepilex on VSB on WELP Mattress | Change in Transcutaneous Tissue Oxygen (TcPO2) | -6 mm Hg | Standard Deviation 16 |
| Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter | Change in Transcutaneous Tissue Oxygen (TcPO2) | -54 mm Hg | Standard Deviation 24 |
| Group 6: PFC Without LiquiCell on Talon Litter | Change in Transcutaneous Tissue Oxygen (TcPO2) | -53 mm Hg | Standard Deviation 17 |
Secondary
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.
Time frame: The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).
Population: All participants exposed to the condition
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest | Change in Pressure-Discomfort (Category Partitioning Scale-50) | 7.7 Scores on a scale | Standard Deviation 8.1 |
| Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest | Change in Pressure-Discomfort (Category Partitioning Scale-50) | 8 Scores on a scale | Standard Deviation 10.4 |
| Group 3: Mepilex on VSB on WELP Mattress | Change in Pressure-Discomfort (Category Partitioning Scale-50) | 9.1 Scores on a scale | Standard Deviation 7.3 |
| Group 4: Without Mepilex on VSB on WELP Mattress | Change in Pressure-Discomfort (Category Partitioning Scale-50) | 5.4 Scores on a scale | Standard Deviation 4.2 |
| Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter | Change in Pressure-Discomfort (Category Partitioning Scale-50) | 8.7 Scores on a scale | Standard Deviation 13.4 |
| Group 6: PFC Without LiquiCell on Talon Litter | Change in Pressure-Discomfort (Category Partitioning Scale-50) | 12.3 Scores on a scale | Standard Deviation 11.1 |