Immobility SyndromeNCT04251897
Novel Support Surface to Alleviate Pressure Ulcer
A study testing Novel support surface in people with Immobility Syndrome and Pressure Ulcer, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Immobility Syndrome, Pressure Ulcer, Pressure Injury
- What is being tested?
- Novel support surface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Sep 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be immobile as assessed on the braden scale.
- Patients must require 2 hourly turning
- Age 21-85
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Tan Tock Seng Hospital Rehabilitation Centre
Singapore, 569766
About this study
Official title: Novel Support Surface Based on Smart Materials to Alleviate Pressure Ulcer Formation During the Rehabilitation of Immobile Patients
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.
- Conditions
- Immobility Syndrome, Pressure Ulcer, Pressure Injury
- Being tested
- Novel support surface
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel support surfaceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Novel support surface |
| 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. Receives: Device: Novel support surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTAUC
pressure-time area under curve
Measured: 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.
Measured: For a maximum of 14 days (duration of trial)
Secondary outcomes (3)
Patient's comfort
Patient comfort measured on a visual analogue scale (1- 10)
Measured: 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.
Measured: 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
Measured: For a maximum of 14 days (duration of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start2 Sep 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immobility SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin Jung Wong, MD, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251897
- Sponsor's protocol ID
- DSRB 2019/00002
- Status last verified
- Apr 2022
- First submitted
- 29 Jan 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Support Surface Based on Smart Materials to Alleviate Pressure Ulcer Formation During the Rehabilitation of Immobile Patients
- ClinicalTrials.gov ID
- NCT04251897
- Acronym / sponsor ID
- DSRB 2019/00002
- Conditions
- Immobility Syndrome, Pressure Ulcer, Pressure Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care mattress | Active comparator | Device: Novel support surfacePatient 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 | Experimental | Device: Novel support surfaceAfter 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be immobile as assessed on the braden scale.
- Patients must require 2 hourly turning
- Age 21-85
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel support surfaceThis 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. | Device | Novel support surface, Standard care mattress |
Primary outcome
PTAUC
Time frame: For a maximum of 14 days (duration of trial)
pressure-time area under curve
Pressure sores - NPUAP (National Pressure Ulcer Advisory Panel) grade
Time frame: 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.
3 secondary outcomes
Patient's comfort
Time frame: For a maximum of 14 days (duration of trial)
Discomfort or pain
Time frame: For a maximum of 14 days (duration of trial)
Suggestions
Time frame: For a maximum of 14 days (duration of trial)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Immobility Syndrome
Active, not recruiting
Mechanisms of Disuse Atrophy in Human Skeletal Muscle (iMOB)
Muscular Atrophy, Immobility Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin Jung Wong, MD principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel support surface in people with Immobility Syndrome and Pressure Ulcer, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTAUC (time frame: For a maximum of 14 days (duration of trial)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.