Pressure InjuryNCT03924622

Pressure Injury Prevention in AE and PFC

A study testing Mepilex and LiquiCell in people with Pressure Injury and Military Activity, run by University of Washington at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Pressure Injury, Military Activity
What is being tested?: Mepilex and LiquiCell
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 20 Jul 2019to 23 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

Previous injuries to sacrum/buttocks with scarring
History of pressure injuries
Cardiovascular disease
Neurological disease that would affect vascular response
Diabetes
History of malignancy

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington School of Nursing
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care

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.

Read the 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.

Conditions: Pressure Injury, Military Activity
Being tested: Mepilex, LiquiCell
Keywords: Pressure injury/prevention, Military Nursing, Risk Reduction
Medical subject headings: Pressure Ulcer, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MepilexDevice
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.
LiquiCellDevice
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 groups in NCT03924622
Study group	Role	What they receive
Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest	Experimental	Intervention: Mepilex Receives: Device: 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 Receives: Device: 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 Receives: Device: LiquiCell
Group 6: PFC Without LiquiCell on Talon Litter	No intervention	Intervention: Control (no LiquiCell)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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.
Measured: The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 201923 Sep 2020

First posted23 Apr 2019
Study start20 Jul 2019
Primary completion23 Sep 2020
Study completion23 Sep 2020

Why it stopped: Unable to continue to conduct study procedures due to pandemic

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pressure InjuryStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03924622
Sponsor's protocol ID: STUDY00006022
Status last verified: Mar 2022
First submitted: 10 Apr 2019
Last updated: 16 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 29606674

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Chronic Ulcers

All Pressure Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care
ClinicalTrials.gov ID: NCT03924622
Acronym / sponsor ID: STUDY00006022
Conditions: Pressure Injury, Military Activity
Keywords: Pressure injury/prevention, Military Nursing, Risk Reduction
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unable to continue to conduct study procedures due to pandemic
Enrolment: 72 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Study start: 20 Jul 2019 (actual)
Primary completion: 23 Sep 2020 (actual)
Study completion: 23 Sep 2020 (actual)
First posted: 23 Apr 2019 (actual)
Results: Posted 16 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6
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.

Arm	Type	Receives
Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest	Experimental	Device: MepilexIntervention: 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	Device: MepilexIntervention: 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	Device: LiquiCellIntervention: LiquiCell mat
Group 6: PFC Without LiquiCell on Talon Litter	No intervention	–Intervention: Control (no LiquiCell)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

Previous injuries to sacrum/buttocks with scarring
History of pressure injuries
Cardiovascular disease
Neurological disease that would affect vascular response
Diabetes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MepilexMepilex 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	Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest, Group 3: Mepilex on VSB on AE mattress
LiquiCellLiquiCell 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.	Device	Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter

Primary outcome

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.

1 secondary outcome

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).

Results and safety

Results posted to the registry on 16 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest	12	10
Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest	12	9
Group 3: Mepilex on VSB on WELP Mattress	12	9
Group 4: Without Mepilex on VSB on WELP Mattress	12	8
Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter	12	9
Group 6: PFC Without LiquiCell on Talon Litter	12	9

Primary outcome: Change in Interleukin-1/Total Protein (Skin)

Time frame: Baseline through study completion - approximately 120 minutes. Mean (Standard Error). Unit: Ratio

Measure	Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest n = 10	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest n = 9	Group 3: Mepilex on VSB on WELP Mattress n = 9	Group 4: Without Mepilex on VSB on WELP Mattress n = 8	Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter n = 9	Group 6: PFC Without LiquiCell on Talon Litter n = 9
Value	-1.9 (2.7)	-0.8 (2.7)	0.13 (2.4)	-4 (2.2)	-3.5 (2.7)	0.14 (0.3)

Primary outcome: Change in Transcutaneous Tissue Oxygen (TcPO2)

Time frame: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods. Mean (Standard Deviation). Unit: mm Hg

Measure	Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest n = 10	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest n = 8	Group 3: Mepilex on VSB on WELP Mattress n = 9	Group 4: Without Mepilex on VSB on WELP Mattress n = 8	Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter n = 4	Group 6: PFC Without LiquiCell on Talon Litter n = 3
Value	-15 (26)	-25 (25)	-4 (23)	-6 (16)	-54 (24)	-53 (17)

Population analysed: 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

Primary outcome: Change in Skin Moisture (Epidermal and Subepidermal)

Time frame: Baseline (before lying down) and after 120 minutes supine. Mean (Standard Deviation). Unit: Tissue Dielectric Constant (TDC)

Measure	Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest n = 10	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest n = 9	Group 3: Mepilex on VSB on WELP Mattress n = 9	Group 4: Without Mepilex on VSB on WELP Mattress n = 8	Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter n = 9	Group 6: PFC Without LiquiCell on Talon Litter n = 9
Value	1.5 (2)	2 (3.8)	1.1 (2.2)	2.1 (2.8)	-0.1 (2)	0.1 (1.3)

Population analysed: All participants exposed to the condition

Primary outcome: Change in Skin Temperature

Time frame: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods. Mean (Standard Deviation). Unit: Degrees centigrade

Measure	Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest n = 10	Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest n = 9	Group 3: Mepilex on VSB on WELP Mattress n = 9	Group 4: Without Mepilex on VSB on WELP Mattress n = 8	Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter n = 9	Group 6: PFC Without LiquiCell on Talon Litter n = 9
Value	3.8 (1.3)	3.1 (1)	3.7 (0.8)	3.2 (1)	2 (2)	1.1 (0.9)

Population analysed: All participants exposed to the condition

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 120 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Mepilex on Litter + WELP Mattress + 30 Degree Backrest	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Group 2: Without Mepilex on Litter + WELP Mattress +30 Degree Backrest	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Group 3: Mepilex on VSB on WELP Mattress	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Group 4: Without Mepilex on VSB on WELP Mattress	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon Litter	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Group 6: PFC Without LiquiCell on Talon Litter	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29606674Bridges 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth Bridges, PhD, RN principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mepilex and LiquiCell in people with Pressure Injury and Military Activity, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Interleukin-1/Total Protein (Skin) (time frame: Baseline through study completion - approximately 120 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03924622, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.