Pressure Injury Prevention in AE and PFC

NCT03924622 | Terminated Results

• 1 other identifier: STUDY00006022
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Injury; Military Activity

Keywords

Pressure injury/prevention; Military Nursing; Risk Reduction

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• 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).

Study Arms (6)

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

EXPERIMENTAL

Intervention: Mepilex

Device: Mepilex

Group 2: Without Mepilex on Litter + AE mattress + backrest

NO INTERVENTION

Intervention: Control (no Mepilex)

Group 3: Mepilex on VSB on AE mattress

EXPERIMENTAL

Intervention: Mepilex

Device: Mepilex

Group 4: Without Mepilex on VSB on AE mattress

NO INTERVENTION

Intervention: Control (no Mepilex)

Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter

EXPERIMENTAL

Intervention: LiquiCell mat

Device: LiquiCell

Group 6: PFC Without LiquiCell on Talon Litter

NO INTERVENTION

Intervention: Control (no LiquiCell)

Interventions

Mepilex DEVICE

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.

Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest; Group 3: Mepilex on VSB on AE mattress

LiquiCell DEVICE

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.

Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington School of Nursing

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 29606674 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Results Point of Contact

• Title: Becky Ostrem CIP Compliance Administrator, Regulatory Affairs
• Organization: University of Washington

bostrem@uw.edu

2066858138

Study Officials

• Elizabeth Bridges, PhD, RN

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Nursing: Dept: Biobehavioral Nursing and Health Informatics

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 23, 2019
• Study Start: July 20, 2019
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: May 16, 2022
• Results First Posted: May 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)