Skip to main content
OpenTrials
Completed

NCT Number: NCT04251897

Novel Support Surface to Alleviate Pressure Ulcer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Immobility Syndrome Pressure Injury Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital Rehabilitation Centre

Singapore, 569766

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. PTAUC

    Time frame: For a maximum of 14 days (duration of trial)

    pressure-time area under curve

  2. 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.

Secondary outcomes

  1. Patient's comfort

    Time frame: For a maximum of 14 days (duration of trial)

    Patient comfort measured on a visual analogue scale (1- 10)

  2. Discomfort or pain

    Time frame: For a maximum of 14 days (duration of trial)

    Presence of discomfort or pain at high risk pressure points. This will be asked of patients, and will be scored as yes or no.

  3. Suggestions

    Time frame: For a maximum of 14 days (duration of trial)

    This will be a qualitative open-ended question for patient's verbatim report or suggestions

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.