Novel Support Surface to Alleviate Pressure Ulcer

NCT ID: NCT04251897

Last Updated: 2022-04-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-02

Study Completion Date

2021-08-30

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.

Detailed Description

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Conditions

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Immobility Syndrome Pressure Ulcer Pressure Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

Novel support surface

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Novel support surface

Intervention Type 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.

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tan Tock Seng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Singapore

Other Identifiers

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DSRB 2019/00002

Identifier Type: -

Identifier Source: org_study_id

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