Clinical trial NCT03924622: Pressure Injury Prevention in AE and PFC
Official title: Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pressure Injury
Military Activity
Keywords: Pressure injury/prevention
Military Nursing
Risk Reduction
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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. Study does not involve FDA-regulated drug.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in Interleukin-1/Total Protein (Skin)
timeFrame: Baseline through study completion - approximately 120 minutes
measure: Change in Transcutaneous Tissue Oxygen (TcPO2)
timeFrame: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
measure: Change in Skin Moisture (Epidermal and Subepidermal)
timeFrame: Baseline (before lying down) and after 120 minutes supine
measure: Change in Skin Temperature
timeFrame: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
measure: Change in Skin Interface Pressure
timeFrame: Continuously during the supine phase of the study (120 minutes)
Secondary outcomes:
measure: Change in Pressure-Discomfort (Category Partitioning Scale-50)
timeFrame: The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington School of Nursing
state: Washington
Study officials:
affiliation: University of Washington
name: Elizabeth Bridges, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.