Pressure Injury Prevention in AE and PFC

Browse trials for

• Pressure Ulcer 518
• Wounds and Injuries 5,056
• Crush Injuries 125

Keywords

• Pressure injury/prevention
• Military Nursing
• Risk Reduction

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's enrollment of 72 is close to the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Study arms

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

  Intervention: Mepilex

  Device: Mepilex

• No intervention
  Group 2: Without Mepilex on Litter + AE mattress + backrest

  Intervention: Control (no Mepilex)

• Experimental
  Group 3: Mepilex on VSB on AE mattress

  Intervention: Mepilex

  Device: Mepilex

• No intervention
  Group 4: Without Mepilex on VSB on AE mattress

  Intervention: Control (no Mepilex)

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

  Intervention: LiquiCell mat

  Device: LiquiCell

• No intervention
  Group 6: PFC Without LiquiCell on Talon Litter

  Intervention: Control (no LiquiCell)

Interventions

• DeviceMepilex

  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.

• DeviceLiquiCell

  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.

Primary outcomes

1. 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)

   Time frame: Baseline through study completion - approximately 120 minutes

2. 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

   Time frame: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods

3. 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.

   Time frame: Baseline (before lying down) and after 120 minutes supine

4. Change in Skin Temperature

   Skin temperature will be measured continuously on the sacrum using a laser doppler probe.

   Time frame: Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods

5. 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.

   Time frame: Continuously during the supine phase of the study (120 minutes)

Secondary outcomes

1. 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.

   Time frame: The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).

Baseline characteristics

Publications

• 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. PubMed 29606674 ↗

Study documents

• Study protocol · Jan 4, 2019
• Statistical analysis plan · Jan 4, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No