Novel Support Surface to Alleviate Pressure Ulcer

Study Overview
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Brief Summary
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A prototype support surface has been designed which aims to successfully redistributes the pressures exerted and provides sufficient support to human soft tissue We want to prove the effectiveness of the prototype support surface by enlisting patients in a clinical trial, where we will assess the presence of pressure ulcers, and the ability of the patients to tolerate the support surface, and also measure the pressure over time and compare them to when the patients are using standard mattresses.

Official Title
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Novel Support Surface Based on Smart Materials to Alleviate Pressure Ulcer Formation During the Rehabilitation of Immobile Patients

Conditions
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Immobility Syndrome, Pressure Ulcer, Pressure Injury

Intervention / Treatment
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* Device: Novel support surface


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be immobile as assessed on the braden scale. Patients must require 2 hourly turning Age 21-85 Exclusion Criteria: No existing pressure ulcers No active infections, fever, or medical conditions that require constant medical attention. They must also not have severe incontinence requiring the change of diapers more frequently than 4 hours No significant cognitive impairment Pregnant women will be excluded from the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care mattress<br>Patient will have 2 days to familiarize with the novel support surface. Patient will be on standard care mattress. They will be turned over every 2 hours for 3 days. | Device: Novel support surface<br>* This is a magnetorheological elastomer that can dynamically redistribute the pressure over a bony prominence to be lower than the critical closing pressure while at the same time providing sufficient support.<br>|
| Experimental: Novel support surface<br>After the standard care mattress, the same patient will be placed on novel support surface. They will be turned over every 2 hours for 3 days. Patient will then continue with the novel support surface and turned every 3 hours for 3 days. They will then continue with the novel support surface and turned every 4 hours for 3 days. | Device: Novel support surface<br>* This is a magnetorheological elastomer that can dynamically redistribute the pressure over a bony prominence to be lower than the critical closing pressure while at the same time providing sufficient support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTAUC | pressure-time area under curve | For a maximum of 14 days (duration of trial) | 
| Pressure sores - NPUAP (National Pressure Ulcer Advisory Panel) grade | If pressure sores are present, they will be graded based on the NPUAP grade from 1-4. Location will also be recorded. | For a maximum of 14 days (duration of trial) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's comfort | Patient comfort measured on a visual analogue scale (1- 10) | For a maximum of 14 days (duration of trial) | 
| Discomfort or pain | Presence of discomfort or pain at high risk pressure points. This will be asked of patients, and will be scored as yes or no. | For a maximum of 14 days (duration of trial) | 
| Suggestions | This will be a qualitative open-ended question for patient's verbatim report or suggestions | For a maximum of 14 days (duration of trial) |