Novel Support Surface to Alleviate Pressure Ulcer

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer; Pressure Injury; Immobility Syndrome
• Intervention / Treatment: Device: Novel support surface

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 569766
    • Tan Tock Seng Hospital Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Investigators: Principal Investigator: Chin Jung Wong, MD, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 2, 2020
• Primary Completion (ACTUAL): August 30, 2021
• Study Completion (ACTUAL): August 30, 2021

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Wounds and Injuries; Skin Ulcer; Ulcer; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: DSRB 2019/00002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No