Trial Outcomes & Findings for Pressure Injury Prevention in AE and PFC (NCT NCT03924622)

Last Updated: 2022-05-16

Results Overview

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)

Recruitment status

TERMINATED

Study phase

Target enrollment

72 participants

Primary outcome timeframe

Baseline through study completion - approximately 120 minutes

Results posted on

2022-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest Intervention: Control (no Mepilex)	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.	Group 4: Without Mepilex on VSB on WELP Mattress Intervention: Control (no Mepilex)	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.	Group 6: PFC Without LiquiCell on Talon Litter Intervention: Control (no LiquiCell)
Overall Study STARTED	12	12	12	12	12	12
Overall Study COMPLETED	10	9	9	8	9	9
Overall Study NOT COMPLETED	2	3	3	4	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest Intervention: Control (no Mepilex)	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.	Group 4: Without Mepilex on VSB on WELP Mattress Intervention: Control (no Mepilex)	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.	Group 6: PFC Without LiquiCell on Talon Litter Intervention: Control (no LiquiCell)
Overall Study Study closed due to pandemic with approval of funding agency/IRB	2	3	3	4	3	3

Baseline Characteristics

Pressure Injury Prevention in AE and PFC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest n=10 Participants 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.	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest n=9 Participants Intervention: Control (no Mepilex) Study surface Litter + WELP mattress pad with 30 degree backrest. No Mepilex	Group 3: Mepilex on VSB on WELP Mattress n=9 Participants 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.	Group 4: Without Mepilex on VSB on WELP Mattress n=8 Participants Intervention: Control (no Mepilex) Litter + WELP mattress + Vacuum Spineboard. No Mepilex	Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter n=9 Participants 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.	Group 6: PFC Without LiquiCell on Talon Litter n=9 Participants Intervention: Control (no LiquiCell) Talon litter	Total n=54 Participants Total of all reporting groups
Age, Continuous	29.0 years STANDARD_DEVIATION 10.6 • n=99 Participants	26.7 years STANDARD_DEVIATION 7.3 • n=107 Participants	25.3 years STANDARD_DEVIATION 12.3 • n=206 Participants	24.8 years STANDARD_DEVIATION 5.9 • n=7 Participants	23.9 years STANDARD_DEVIATION 8.8 • n=31 Participants	25 years STANDARD_DEVIATION 8 • n=30 Participants	29 years STANDARD_DEVIATION 12 • n=3 Participants
Sex: Female, Male Female	8 Participants n=99 Participants	6 Participants n=107 Participants	6 Participants n=206 Participants	6 Participants n=7 Participants	6 Participants n=31 Participants	8 Participants n=30 Participants	40 Participants n=3 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	2 Participants n=7 Participants	3 Participants n=31 Participants	1 Participants n=30 Participants	14 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=99 Participants	8 Participants n=107 Participants	9 Participants n=206 Participants	8 Participants n=7 Participants	9 Participants n=31 Participants	9 Participants n=30 Participants	53 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	5 Participants n=107 Participants	5 Participants n=206 Participants	5 Participants n=7 Participants	4 Participants n=31 Participants	4 Participants n=30 Participants	26 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	2 Participants n=7 Participants	5 Participants n=31 Participants	5 Participants n=30 Participants	24 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	2 Participants n=3 Participants
Body Fat Percent	29 Percent body fat STANDARD_DEVIATION 10.6 • n=99 Participants	26.7 Percent body fat STANDARD_DEVIATION 7.3 • n=107 Participants	25.3 Percent body fat STANDARD_DEVIATION 12.3 • n=206 Participants	24.8 Percent body fat STANDARD_DEVIATION 5.9 • n=7 Participants	23.9 Percent body fat STANDARD_DEVIATION 8.8 • n=31 Participants	25.0 Percent body fat STANDARD_DEVIATION 8.0 • n=30 Participants	25.8 Percent body fat STANDARD_DEVIATION 8.9 • n=3 Participants

PRIMARY outcome

Timeframe: Baseline through study completion - approximately 120 minutes

Outcome measures

Outcome measures
Measure	Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest n=10 Participants 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.	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest n=9 Participants Intervention: Control (no Mepilex) Study surface Litter + WELP mattress pad with 30 degree backrest. No Mepilex	Group 3: Mepilex on VSB on WELP Mattress n=9 Participants 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.	Group 4: Without Mepilex on VSB on WELP Mattress n=8 Participants Intervention: Control (no Mepilex) Litter + WELP mattress + Vacuum Spineboard. No Mepilex	Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter n=9 Participants 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.	Group 6: PFC Without LiquiCell on Talon Litter n=9 Participants Intervention: Control (no LiquiCell) Talon litter
Change in Interleukin-1/Total Protein (Skin)	-1.9 Ratio Standard Error 2.7	-0.8 Ratio Standard Error 2.7	0.13 Ratio Standard Error 2.4	-4 Ratio Standard Error 2.2	-3.5 Ratio Standard Error 2.7	0.14 Ratio Standard Error 0.3

PRIMARY outcome

Timeframe: 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

Tissue oxygen is measured continuously on the sacrum using a noninvasive sensor and on the midsternum (midchest) as a control

Outcome measures

Outcome measures
Measure	Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest n=10 Participants 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.	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest n=8 Participants Intervention: Control (no Mepilex) Study surface Litter + WELP mattress pad with 30 degree backrest. No Mepilex	Group 3: Mepilex on VSB on WELP Mattress n=9 Participants 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.	Group 4: Without Mepilex on VSB on WELP Mattress n=8 Participants Intervention: Control (no Mepilex) Litter + WELP mattress + Vacuum Spineboard. No Mepilex	Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter n=4 Participants 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.	Group 6: PFC Without LiquiCell on Talon Litter n=3 Participants Intervention: Control (no LiquiCell) Talon litter
Change in Transcutaneous Tissue Oxygen (TcPO2)	-15 mm Hg Standard Deviation 26	-25 mm Hg Standard Deviation 25	-4 mm Hg Standard Deviation 23	-6 mm Hg Standard Deviation 16	-54 mm Hg Standard Deviation 24	-53 mm Hg Standard Deviation 17

PRIMARY outcome

Timeframe: Baseline (before lying down) and after 120 minutes supine

Population: All participants exposed to the condition

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.

Outcome measures

Outcome measures
Measure	Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest n=10 Participants 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.	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest n=9 Participants Intervention: Control (no Mepilex) Study surface Litter + WELP mattress pad with 30 degree backrest. No Mepilex	Group 3: Mepilex on VSB on WELP Mattress n=9 Participants 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.	Group 4: Without Mepilex on VSB on WELP Mattress n=8 Participants Intervention: Control (no Mepilex) Litter + WELP mattress + Vacuum Spineboard. No Mepilex	Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter n=9 Participants 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.	Group 6: PFC Without LiquiCell on Talon Litter n=9 Participants Intervention: Control (no LiquiCell) Talon litter
Change in Skin Moisture (Epidermal and Subepidermal)	1.5 Tissue Dielectric Constant (TDC) Standard Deviation 2	2 Tissue Dielectric Constant (TDC) Standard Deviation 3.8	1.1 Tissue Dielectric Constant (TDC) Standard Deviation 2.2	2.1 Tissue Dielectric Constant (TDC) Standard Deviation 2.8	-0.1 Tissue Dielectric Constant (TDC) Standard Deviation 2	0.1 Tissue Dielectric Constant (TDC) Standard Deviation 1.3

PRIMARY outcome

Timeframe: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods

Population: All participants exposed to the condition

Skin temperature will be measured continuously on the sacrum using a laser doppler probe.

Outcome measures

Outcome measures
Measure	Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest n=10 Participants 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.	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest n=9 Participants Intervention: Control (no Mepilex) Study surface Litter + WELP mattress pad with 30 degree backrest. No Mepilex	Group 3: Mepilex on VSB on WELP Mattress n=9 Participants 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.	Group 4: Without Mepilex on VSB on WELP Mattress n=8 Participants Intervention: Control (no Mepilex) Litter + WELP mattress + Vacuum Spineboard. No Mepilex	Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter n=9 Participants 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.	Group 6: PFC Without LiquiCell on Talon Litter n=9 Participants Intervention: Control (no LiquiCell) Talon litter
Change in Skin Temperature	3.8 Degrees centigrade Standard Deviation 1.3	3.1 Degrees centigrade Standard Deviation 1	3.7 Degrees centigrade Standard Deviation 0.8	3.2 Degrees centigrade Standard Deviation 1	2 Degrees centigrade Standard Deviation 2	1.1 Degrees centigrade Standard Deviation 0.9

PRIMARY outcome

Timeframe: Continuously during the supine phase of the study (120 minutes)

Population: All participants exposed to the condition

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.

Outcome measures

Outcome measures
Measure	Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest n=10 Participants 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.	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest n=9 Participants Intervention: Control (no Mepilex) Study surface Litter + WELP mattress pad with 30 degree backrest. No Mepilex	Group 3: Mepilex on VSB on WELP Mattress n=9 Participants 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.	Group 4: Without Mepilex on VSB on WELP Mattress n=8 Participants Intervention: Control (no Mepilex) Litter + WELP mattress + Vacuum Spineboard. No Mepilex	Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter n=9 Participants 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.	Group 6: PFC Without LiquiCell on Talon Litter n=9 Participants Intervention: Control (no LiquiCell) Talon litter
Change in Skin Interface Pressure	46 mm Hg Standard Deviation 8	52 mm Hg Standard Deviation 10	52 mm Hg Standard Deviation 10	66 mm Hg Standard Deviation 22	66 mm Hg Standard Deviation 27	78 mm Hg Standard Deviation 47

SECONDARY outcome

Timeframe: 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

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.