Pressure Injury Clinical Trial
Official title:
Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care
Verified date | March 2022 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 72 |
Est. completion date | September 23, 2020 |
Est. primary completion date | September 23, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington School of Nursing | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Baseline through study completion - approximately 120 minutes | |
Primary | 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 continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods | |
Primary | 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. | Baseline (before lying down) and after 120 minutes supine | |
Primary | Change in Skin Temperature | Skin temperature will be measured continuously on the sacrum using a laser doppler probe. | Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods | |
Primary | 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. | Continuously during the supine phase of the study (120 minutes) | |
Secondary | 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. | The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements). |
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