Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care

Pressure Injury Prevention in AE and PFC

Sponsors

Lead sponsor: University of Washington

Source University of Washington
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.

Overall Status Recruiting
Start Date July 20, 2019
Completion Date September 2020
Primary Completion Date September 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Interleukin-1/Total Protein (skin) Baseline through study completion - approximately 120 minutes
Change in Transcutaneous tissue oxygen (TcPO2) Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
Change in Skin Moisture (epidermal and subepidermal) Baseline (before lying down) and after 120 minutes supine
Change in Skin Temperature Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
Change in Skin interface pressure Continuously during the supine phase of the study (120 minutes)
Secondary Outcome
Measure Time Frame
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).
Enrollment 72
Condition
Intervention

Intervention type: Device

Intervention name: Mepilex

Description: 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.

Intervention type: Device

Intervention name: LiquiCell

Description: 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.

Arm group label: Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 55 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Elizabeth Bridges, PhD, RN Principal Investigator University of Washington
Overall Contact

Last name: Elizabeth Bridges, PhD, RN

Phone: 206-543-6250

Email: [email protected]

Location
facility status contact University of Washington School of Nursing Research Nurse 206-685-5660
Location Countries

United States

Verification Date

July 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Washington

Investigator full name: Elizabeth Bridges

Investigator title: Professor, School of Nursing: Dept: Biobehavioral Nursing and Health Informatics

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Arm group label: Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest

Arm group type: Experimental

Description: Intervention: Mepilex

Arm group label: Group 2: Without Mepilex on Litter + AE mattress + backrest

Arm group type: No Intervention

Description: Intervention: Control (no Mepilex)

Arm group label: Group 3: Mepilex on VSB on AE mattress

Arm group type: Experimental

Description: Intervention: Mepilex

Arm group label: Group 4: Without Mepilex on VSB on AE mattress

Arm group type: No Intervention

Description: Intervention: Control (no Mepilex)

Arm group label: Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter

Arm group type: Experimental

Description: Intervention: LiquiCell mat

Arm group label: Group 6: PFC Without LiquiCell on Talon Litter

Arm group type: No Intervention

Description: Intervention: Control (no LiquiCell)

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

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.

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov