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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care mattress | Active Comparator | 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. |
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| Novel support surface | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel support surface | Device | 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. |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chin Jung Wong, MD | Tan Tock Seng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tan Tock Seng Hospital Rehabilitation Centre | Singapore | 569766 | Singapore |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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) |