AzTrials
AzTrials

Pressure UlcerNCT02325388

Pressure Sensing to Reduce the Risk of Pressure Ulcer Formation

A study testing ForeSite PT™ system in people with Pressure Ulcer, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Pressure ulcers are prevalent conditions that result in substantial financial costs to the healthcare system as well as significant distress to affected patients and their families. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pressure Ulcer
What is being tested?
ForeSite PT™ system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
678 participants
Where
1 siteCanada
Study dates
Dec 2014to 10 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult, man or woman, with a minimum age limit of 18 years old.
  • Expected to have a length of stay on the unit of at least three days.
  • Require assistance with bed mobility or completely dependent for bed mobility as determined by the "Bed" components in the de Morton Mobility Index (DEMMI). Eligible patients would be:
  • Unable (score of "0") to bridge, roll onto their side, and sit from lying supine.
  • Unable (score of "0") to bridge and roll onto their side, and requires minimal assistance and/or supervision with sitting from lying supine.
  • Able (score of "1") to bridge, unable to roll onto their side (score of "0"), and requires minimal assistance and/or supervision with sitting from lying supine.
  • Capacity to provide consent, or have a surrogate decision-maker provide consent on their behalf.
  • Not near the end of life within three days of enrolment in the study.

Who cannot join

  • Have a planned admission to another unit (including those identified as a setting for data collection in the study) within three days of enrolment in the study.
  • Sleep in a chair at night.
  • Whose clinical care would be negatively impacted if turned or repositioned.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Calgary

    Calgary, Alberta

Other trials in Canada

About this study

Official title: Effectiveness of a Pressure-sensing System to Reduce the Risk of Pressure Ulcer Formation by Lowering Interface Pressure in Vulnerable Patient Populations: A Parallel-two-group Randomized Controlled Trial

Pressure ulcers are prevalent conditions that result in substantial financial costs to the healthcare system as well as significant distress to affected patients and their families. This study is a parallel two-group randomized controlled trial that aims to study how the use of a pressure sensing device with continuous visual feedback of pressure imaging may potentially decrease the interface pressure of patients who are at risk of pressure ulcers in an acute hospital setting.

Read the detailed description

Background: Pressure ulcers result in substantial financial costs to the healthcare system as well as significant distress to affected patients and their families. As interface pressure is a key risk factor in the development of pressure ulcers, continuous visual feedback of continuous pressure imaging (CPI) between the body and support surface could inform healthcare providers on repositioning strategies and play a key role in an overall strategy for the prevention and management of pressure ulcers. This randomized, controlled trial aims to study the effect of CPI on the reduction of interface pressure, and the incidence of pressure ulcers in vulnerable hospital patients.

Methods: A parallel two-group randomized controlled clinical trial will be conducted. A total of 678 eligible consenting inpatients at high risk of pressure ulcer development in a tertiary acute care institution will be randomly allocated to either have the ForeSite PT™ system with the liquid-crystal display ("LCD") monitor turned on to provide visual feedback through CPI to healthcare providers while also collecting continuous interface pressure data (intervention group), or have the ForeSite PT™ system with the LCD monitor turned off, therefore not providing visual feedback or CPI to healthcare providers, while collecting continuous interface pressure data in the background (control group), in a ratio of 1:1. Data will be collected on both groups for three days (72 hours). The primary outcome will be the differences in the two groups' interface pressure analysis. The interface pressure readings will be collected through hourly sampling of continuous interface pressure recordings taken throughout this study period. Clinical outcomes will be the differences in the two groups' pressure-related skin and soft tissue change in areas at risk of pressure ulcer. It will be obtained at baseline (within 24 hours of admission) and on the third day of the trial. Perceptions of intervention patients and healthcare providers will be obtained on the third day.

Discussion: This will be the first randomized controlled trial to investigate the effect of CPI on interface pressure of vulnerable hospital patients, and the association between interface pressure and development of pressure-related skin and soft tissue changes. The results could provide important information to guide clinical practice in the prevention and management of pressure ulcers.

Conditions
Pressure Ulcer
Being tested
ForeSite PT™ system
Keywords
pressure ulcer, decubitus ulcer, bed sore, continuous pressure mapping, interface pressure imaging
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ForeSite PT™ systemDevice

    XSENSOR Technology Corporation's ForeSite PT™ Patient Turn System (referred to as the "ForeSite PT™ system") continuously monitors interface pressure and provides CPI that quantifies real-time interface pressure information. It also provides patient turn tracking to assist with management of the patient turn schedule by alerting healthcare providers and/or caregivers to the location of body areas that have experienced the greatest exposure, and when the next turn/repositioning is due as per pre-set alerts.

Study groups in NCT02325388
Study groupRoleWhat they receive
Treatment group with ForeSite PT™ systemExperimentalInpatients assigned to the treatment group with the ForeSite PT™ system will have its LCD monitor turned on (i.e., real-time images of interface pressure will be displayed on the monitor) during their enrolment in the trial.
Receives: Device: ForeSite PT™ system
Control groupNo interventionInpatients assigned to the control group will have the ForeSite PT™ system's LCD monitor turned off and hidden (i.e., real-time images of interface pressure will not be displayed on the monitor). As the ForeSite PT™ system will continue to record interface pressure with the display turned off, this enables patients enrolled in the control group to undergo silent monitoring.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interface pressure analysis - peak pressure

    Peak pressure of any given pressure reading sample

    Measured: 72 hours

  2. Interface pressure analysis - sensel pressure reading

    Absolute number of sensels with pressure readings greater than 40 mmHg

    Measured: 72 hours

  3. Interface pressure analysis - average pressure

    Average interface pressure (excluding sensels with 0mmHg reading)

    Measured: 72 hours

  4. Interface pressure analysis - % with pressure over 40mmHg

    Proportion of participants that have pressure readings greater than 40 mmHg

    Measured: 72 hours

Secondary outcomes (3)

  1. Pressure related skin and soft tissue changes

    Any change in the skin appearance, pressure ulcer formation, skin/wound infection

    Measured: 72 hours

  2. Perceptions of healthcare providers

    Survey of healthcare providers on prior experience with pressure mapping technology, functionality, ease of use, and interpretation of pressure data on the LCD monitor.

    Measured: 72 hours

  3. Perceptions of patients

    Survey of patients on prior and current experience with CPI (including sensor mattress cover and monitor display of their pressure distribution) on their care and comfort.

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion7 May 2018
  4. Study completion10 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
678 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02325388
Sponsor's protocol ID
REB13-0794
Status last verified
May 2019
First submitted
17 Dec 2014
Last updated
16 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Ho C, Ocampo W, Southern DA, Sola D, Baylis B, Conly JM, Hogan DB, Kaufman J, Stelfox HT, Ghali WA. Effect of a Continuous Bedside Pressure Mapping System for Reducing Interface Pressures: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2316480. doi: 10.1001/jamanetworkopen.2023.16480.

    PubMed 37266939

  • Wong H, Kaufman J, Baylis B, Conly JM, Hogan DB, Stelfox HT, Southern DA, Ghali WA, Ho CH. Efficacy of a pressure-sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial. Trials. 2015 Sep 29;16:434. doi: 10.1186/s13063-015-0949-x.

    PubMed 26420303

Questions about this trial

What is this clinical trial studying?

A study testing ForeSite PT™ system in people with Pressure Ulcer, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interface pressure analysis - peak pressure (time frame: 72 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02325388, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in