Immobility Syndrome, Pressure Injury, Pressure Ulcer
Conditions
Brief summary
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.
Interventions
DEVICENovel support surface
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.
Sponsors
Tan Tock Seng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must be immobile as assessed on the braden scale. 2. Patients must require 2 hourly turning 3. Age 21-85
Exclusion criteria
1. No existing pressure ulcers 2. No active infections, fever, or medical conditions that require constant medical attention. 3. They must also not have severe incontinence requiring the change of diapers more frequently than 4 hours 4. No significant cognitive impairment 5. Pregnant women will be excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTAUC | For a maximum of 14 days (duration of trial) | pressure-time area under curve |
| Pressure sores - NPUAP (National Pressure Ulcer Advisory Panel) grade | For a maximum of 14 days (duration of trial) | If pressure sores are present, they will be graded based on the NPUAP grade from 1-4. Location will also be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's comfort | For a maximum of 14 days (duration of trial) | Patient comfort measured on a visual analogue scale (1- 10) |
| Discomfort or pain | For a maximum of 14 days (duration of trial) | Presence of discomfort or pain at high risk pressure points. This will be asked of patients, and will be scored as yes or no. |
| Suggestions | For a maximum of 14 days (duration of trial) | This will be a qualitative open-ended question for patient's verbatim report or suggestions |
Countries
Singapore
Outcome results
None listed