Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2020-09-02
2021-08-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Standard care mattress
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.
Novel 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.
Novel support surface
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.
Novel 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.
Interventions
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Novel 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.
Eligibility Criteria
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Inclusion Criteria
2. Patients must require 2 hourly turning
3. Age 21-85
Exclusion Criteria
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
21 Years
85 Years
ALL
No
Sponsors
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Tan Tock Seng Hospital
OTHER
Responsible Party
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Principal Investigators
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Chin Jung Wong, MD
Role: PRINCIPAL_INVESTIGATOR
Tan Tock Seng Hospital
Locations
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Tan Tock Seng Hospital Rehabilitation Centre
Singapore, , Singapore
Countries
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Other Identifiers
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DSRB 2019/00002
Identifier Type: -
Identifier Source: org_study_id
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