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Novel Support Surface to Alleviate Pressure Ulcer

Primary Purpose

Immobility Syndrome, Pressure Ulcer, Pressure Injury

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Novel support surface
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immobility Syndrome

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tan Tock Seng Hospital Rehabilitation Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care mattress

Novel support surface

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PTAUC
pressure-time area under curve
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.

Secondary Outcome Measures

Patient's comfort
Patient comfort measured on a visual analogue scale (1- 10)
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.
Suggestions
This will be a qualitative open-ended question for patient's verbatim report or suggestions

Full Information

First Posted
January 29, 2020
Last Updated
April 26, 2022
Sponsor
Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04251897
Brief Title
Novel Support Surface to Alleviate Pressure Ulcer
Official Title
Novel Support Surface Based on Smart Materials to Alleviate Pressure Ulcer Formation During the Rehabilitation of Immobile Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tan Tock Seng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immobility Syndrome, Pressure Ulcer, Pressure Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care mattress
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Novel support surface
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Novel support surface
Intervention Description
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 Outcome Measure Information:
Title
PTAUC
Description
pressure-time area under curve
Time Frame
For a maximum of 14 days (duration of trial)
Title
Pressure sores - NPUAP (National Pressure Ulcer Advisory Panel) grade
Description
If pressure sores are present, they will be graded based on the NPUAP grade from 1-4. Location will also be recorded.
Time Frame
For a maximum of 14 days (duration of trial)
Secondary Outcome Measure Information:
Title
Patient's comfort
Description
Patient comfort measured on a visual analogue scale (1- 10)
Time Frame
For a maximum of 14 days (duration of trial)
Title
Discomfort or pain
Description
Presence of discomfort or pain at high risk pressure points. This will be asked of patients, and will be scored as yes or no.
Time Frame
For a maximum of 14 days (duration of trial)
Title
Suggestions
Description
This will be a qualitative open-ended question for patient's verbatim report or suggestions
Time Frame
For a maximum of 14 days (duration of trial)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin Jung Wong, MD
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital Rehabilitation Centre
City
Singapore
ZIP/Postal Code
569766
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Novel Support Surface to Alleviate Pressure Ulcer

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