Novel Support Surface to Alleviate Pressure Ulcer

NCT04251897 | Completed DMC

• 1 other identifier: DSRB 2019/00002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immobility Syndrome; Pressure Ulcer; Pressure Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Patient's comfort

  For a maximum of 14 days (duration of trial)

• Discomfort or pain

  For a maximum of 14 days (duration of trial)

• Suggestions

  For a maximum of 14 days (duration of trial)

Study Arms (2)

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.

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.

Device: Novel support surface

Interventions

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.

Novel support surface; Standard care mattress

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be immobile as assessed on the braden scale.
• Patients must require 2 hourly turning
• Age 21-85

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital Rehabilitation Centre

Singapore, 569766, Singapore

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chin Jung Wong, MD

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 5, 2020
• Study Start: September 2, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)