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Unable to continue to conduct study procedures due to pandemic
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest | Experimental | Intervention: Mepilex |
|
| Group 2: Without Mepilex on Litter + AE mattress + backrest | No Intervention | Intervention: Control (no Mepilex) | |
| Group 3: Mepilex on VSB on AE mattress | Experimental | Intervention: Mepilex |
|
| Group 4: Without Mepilex on VSB on AE mattress | No Intervention | Intervention: Control (no Mepilex) | |
| Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter | Experimental | Intervention: LiquiCell mat |
|
| Group 6: PFC Without LiquiCell on Talon Litter | No Intervention | Intervention: Control (no LiquiCell) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline through study completion - approximately 120 minutes |
| 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 | Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods |
| 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. | Baseline (before lying down) and after 120 minutes supine |
| Change in Skin Temperature | Skin temperature will be measured continuously on the sacrum using a laser doppler probe. | Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods |
| 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. | Continuously during the supine phase of the study (120 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Bridges, PhD, RN | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington School of Nursing | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29606674 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest | Intervention: Mepilex 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. |
| FG001 | Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest | Intervention: Control (no Mepilex) |
| FG002 | Group 3: Mepilex on VSB on WELP Mattress | Intervention: Mepilex 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. |
| FG003 | Group 4: Without Mepilex on VSB on WELP Mattress | Intervention: Control (no Mepilex) |
| FG004 | Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter | Intervention: LiquiCell mat 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. |
| FG005 | Group 6: PFC Without LiquiCell on Talon Litter | Intervention: Control (no LiquiCell) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All individuals with baseline data
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Error | Ratio | Baseline through study completion - approximately 120 minutes |
|
120 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Becky Ostrem CIP Compliance Administrator, Regulatory Affairs | University of Washington | 2066858138 | bostrem@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 4, 2019 | Dec 3, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 4, 2019 | Mar 1, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
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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.
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| LiquiCell | Device | 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. |
|
| The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements). |
| BG001 | 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 |
| BG002 | 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. |
| BG003 | Group 4: Without Mepilex on VSB on WELP Mattress | Intervention: Control (no Mepilex) Litter + WELP mattress + Vacuum Spineboard. No Mepilex |
| BG004 | 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. |
| BG005 | Group 6: PFC Without LiquiCell on Talon Litter | Intervention: Control (no LiquiCell) Talon litter |
| BG006 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Fat Percent | Mean | Standard Deviation | Percent body fat |
|
| 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 |
| OG002 | 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. |
| OG003 | Group 4: Without Mepilex on VSB on WELP Mattress | Intervention: Control (no Mepilex) Litter + WELP mattress + Vacuum Spineboard. No Mepilex |
| OG004 | 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. |
| OG005 | Group 6: PFC Without LiquiCell on Talon Litter | Intervention: Control (no LiquiCell) Talon litter |
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | mm Hg | Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods |
|
|
|
| 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. | All participants exposed to the condition | Posted | Mean | Standard Deviation | Tissue Dielectric Constant (TDC) | Baseline (before lying down) and after 120 minutes supine |
|
|
|
| Primary | Change in Skin Temperature | Skin temperature will be measured continuously on the sacrum using a laser doppler probe. | All participants exposed to the condition | Posted | Mean | Standard Deviation | Degrees centigrade | Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods |
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|
|
| 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. | All participants exposed to the condition | Posted | Mean | Standard Deviation | mm Hg | Continuously during the supine phase of the study (120 minutes) |
|
|
|
| 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. | All participants exposed to the condition | Posted | Mean | Standard Deviation | Scores on a scale | The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements). |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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 | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Group 4: Without Mepilex on VSB on WELP Mattress | Intervention: Control (no Mepilex) Litter + WELP mattress + Vacuum Spineboard. No Mepilex | 0 | 8 | 0 | 8 | 0 | 8 |
| EG004 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG005 | Group 6: PFC Without LiquiCell on Talon Litter | Intervention: Control (no LiquiCell) Talon litter | 0 | 9 | 0 | 9 | 0 | 9 |
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