Pressure Injury Prevention in AE and PFC
1. marts 2022 opdateret af: Elizabeth Bridges, University of Washington
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
72
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98195
- University of Washington School of Nursing
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest
Intervention: 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.
|
|
Ingen indgriben: Group 2: Without Mepilex on Litter + AE mattress + backrest
Intervention: Control (no Mepilex)
|
|
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Eksperimentel: Group 3: Mepilex on VSB on AE mattress
Intervention: 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.
|
|
Ingen indgriben: Group 4: Without Mepilex on VSB on AE mattress
Intervention: Control (no Mepilex)
|
|
|
Eksperimentel: Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter
Intervention: LiquiCell mat
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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.
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Ingen indgriben: Group 6: PFC Without LiquiCell on Talon Litter
Intervention: Control (no LiquiCell)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Interleukin-1/Total Protein (Skin)
Tidsramme: 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)
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Baseline through study completion - approximately 120 minutes
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Change in Transcutaneous Tissue Oxygen (TcPO2)
Tidsramme: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Tissue oxygen is measured continuously on the sacrum using a noninvasive sensor and on the midsternum (midchest) as a control
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Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Change in Skin Moisture (Epidermal and Subepidermal)
Tidsramme: Baseline (before lying down) and after 120 minutes supine
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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.
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Baseline (before lying down) and after 120 minutes supine
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Change in Skin Temperature
Tidsramme: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Skin temperature will be measured continuously on the sacrum using a laser doppler probe.
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Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Change in Skin Interface Pressure
Tidsramme: Continuously during the supine phase of the study (120 minutes)
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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.
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Continuously during the supine phase of the study (120 minutes)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pressure-Discomfort (Category Partitioning Scale-50)
Tidsramme: The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).
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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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The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Elizabeth Bridges, PhD, RN, University of Washington
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. juli 2019
Primær færdiggørelse (Faktiske)
23. september 2020
Studieafslutning (Faktiske)
23. september 2020
Datoer for studieregistrering
Først indsendt
10. april 2019
Først indsendt, der opfyldte QC-kriterier
19. april 2019
Først opslået (Faktiske)
23. april 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00006022
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