Novel Support Surface to Alleviate Pressure Ulcer

Pressure Ulcer Clinical Trial

Official title:

Novel Support Surface Based on Smart Materials to Alleviate Pressure Ulcer Formation During the Rehabilitation of Immobile Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251897
• Other study ID #: DSRB 2019/00002
• Status: Completed
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: April 2022
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Immobility Syndrome
• Pressure Injury
• Pressure Ulcer
• Ulcer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital Rehabilitation Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTAUC	pressure-time area under curve	For a maximum of 14 days (duration of trial)
Primary	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)
Secondary	Patient's comfort	Patient comfort measured on a visual analogue scale (1- 10)	For a maximum of 14 days (duration of trial)
Secondary	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.	For a maximum of 14 days (duration of trial)
Secondary	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)