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Novel Support Surface to Alleviate Pressure Ulcer

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ClinicalTrials.gov Identifier: NCT04251897
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Tan Tock Seng Hospital

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.


Condition or disease Intervention/treatment Phase
Immobility Syndrome Pressure Ulcer Pressure Injury Device: Novel support surface Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Novel Support Surface Based on Smart Materials to Alleviate Pressure Ulcer Formation During the Rehabilitation of Immobile Patients
Actual Study Start Date : September 2, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251897


Contacts
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Contact: Chin Jung Wong, MD 64506225 chin_jung_wong@ttsh.com.sg

Locations
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Singapore
Tan Tock Seng Hospital Rehabilitation Centre Recruiting
Singapore, Singapore, 569766
Contact: Chin Jung Wong, MD    64506225    chin_jung_wong@ttsh.com.sg   
Sponsors and Collaborators
Tan Tock Seng Hospital
Investigators
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Principal Investigator: Chin Jung Wong, MD Tan Tock Seng Hospital
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Responsible Party: Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT04251897    
Other Study ID Numbers: DSRB 2019/00002
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Crush Injuries
Pathologic Processes
Skin Ulcer
Skin Diseases
Wounds and Injuries