Clinical Trials Directory

Trials / Terminated

TerminatedNCT03924622

Pressure Injury Prevention in AE and PFC

Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEMepilexMepilex 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.
DEVICELiquiCellLiquiCell 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.

Timeline

Start date
2019-07-20
Primary completion
2020-09-23
Completion
2020-09-23
First posted
2019-04-23
Last updated
2022-05-16
Results posted
2022-05-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03924622. Inclusion in this directory is not an endorsement.