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Pressure UlcersNCT02690753

Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning

A study testing A protocol tailored to individual risk factors, The Prevalon® Turn and Position System 2.0 and Comfort Shield® barrier cream cloths in people with Pressure Ulcers and Incontinence-associated Dermatitis, run by University Ghent at 15 sites in Belgium.

Completed

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

Official record
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Trial summary

The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors are pressure or pressure combined with shear. Prevention is very important and comprises: preventive skin care including cleansing and protecting the skin from exposure to moisture, the systematic repositioning of the patient… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
A protocol tailored to individual risk factors, The Prevalon® Turn and Position System 2.0 and Comfort Shield® barrier cream cloths
Could I receive a placebo?
No, everyone receives an active treatment
How many people
227 participants
Where
15 sitesBelgium
Study dates
Feb 2016to Dec 2017
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • At risk of developing pressure ulcers (Braden score < 17)
  • Maximum 24hours admitted on the ward at the time of inclusion
  • Expected lenght of stay: 8 days
  • Free of pressure ulcers category II, II, IV and incontinence-associated dermatitis (IAD) category 2 at the start of the study

Who cannot join

  • Patients with no active or supportive therapy

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Belgium15 sites

  • ASZ Aalst

    Aalst

  • AZ Monica

    Antwerp

  • ZNA Hoge Beuken

    Antwerp

  • ZNA St. Elisabeth

    Antwerp

  • AZ Nikolaas campus Beveren

    Beveren, Oost-Vlaanderen

  • Imelda Ziekenhuis

    Bonheiden

  • AZ St. Jan Brugge

    Bruges

  • AZ St. Maarten

    Duffel, Antwerpen, 2570

  • AZ St. Dimpna

    Geel, Antwerpen

  • ASZ Geraardsbergen

    Geraardsbergen

  • UZ Gent

    Ghent, Oost-Vlaanderen

  • AZ Delta Menen

    Menen

  • AZ St. Jan Oostende

    Ostend

  • AZ Oudenaarde

    Oudenaarde, Oost-Vlaanderen, 9700

  • AZ Delta Roeselare

    Roeselare

Other trials in Belgium

About this study

Official title: A Turn and Positioning System and Standardized Incontinence Care Combined With Tailored Repositioning Versus a Standard Repositioning Protocol for Pressure Ulcer Prevention: A Multicenter Prospective Randomized Controlled Clinical Trial and Health Economical Analysis in a Hospital Setting

The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors are pressure or pressure combined with shear. Prevention is very important and comprises: preventive skin care including cleansing and protecting the skin from exposure to moisture, the systematic repositioning of the patient, the offloading of the heels from the surface of the bed, the use of adequate bed support surfaces and an adequate nutritional status. The development and implementation of a risk based prevention plan for individuals identified as being at risk is strongly recommended. Limited compliance exists towards pressure ulcer preventive interventions. 25,5% of the patients at risk receive fully adequate prevention in bed. The reposition frequence is adequate in 55% of patients at risk. There is a lack of rigorously performed research addressing the effectiveness of devices or risk based protocols to improve compliance. Health care budgets are limited, priorities should be set in the allocation of health care resources.

The primary aim of this study is to compare the effectiveness of the turn and position system (Prevalon®Turn and Position System 2.0, SAGE) versus standard care to improve reposition frequence in patients at risk. The second aim is to compare the effectiveness of a tailored protocol versus standard care to improve reposition frequence in patients at risk. The third aim is to compare the effectiveness of standardized incontinence care versus standard care to improve the incidence of pressure ulcers and incontinence-associated dermatitis (IAD). Also a health economic evaluation will be performed.

The study will be performed in hospital setting (university and general hospitals) in a random sample of 226 patients aged > 18 who are at risk of developing pressure ulcers. Patients will be recruited from three types of wards: intensive care units, geriatric wards and rehabilitation wards. Patients will be included in the study for a period of 8 days.

Being tested
A protocol tailored to individual risk factors, The Prevalon® Turn and Position System 2.0, Comfort Shield® barrier cream cloths
Keywords
Repositioning, Incontinence care, Prevention
Medical subject headings
Pressure Ulcer

What participants receive

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

  • A protocol tailored to individual risk factorsProcedure or surgery

  • The Prevalon® Turn and Position System 2.0Device

  • Comfort Shield® barrier cream clothsDevice

Study groups in NCT02690753
Study groupRoleWhat they receive
Tailored repositioning + Standardised incontinence care + TAPExperimentalA protocol tailored to individual risk factors will be applied to patients at risk.Comfort Shield® barrier cream cloths will be used for incontinence care every morning and after each episode of incontinence. The Prevalon® Turn and Position System 2.0, SAGE will be used for turning and positioning patients at risk when laying in bed.
Receives: Procedure: A protocol tailored to individual risk factors; Device: The Prevalon® Turn and Position System 2.0; Device: Comfort Shield® barrier cream cloths
Standard repositioning + Standardised incontinence care + TAPExperimentalInstead of developing and using a tailored pressure ulcer prevention protocol, patients will receive standard care.Comfort Shield® barrier cream cloths will be used for incontinence care every morning and after each episode of incontinence. The Prevalon® Turn and Position System 2.0, SAGE will be used for turning and positioning patients at risk when laying in bed.
Receives: Device: The Prevalon® Turn and Position System 2.0; Device: Comfort Shield® barrier cream cloths
Usual careNo interventionInstead of developing and using a tailored pressure ulcer prevention protocol, patients will receive standard care. Instead of using comfort Shield® barrier cream cloths, incontinence care will be given to patients using the standard procedure on the ward. Instead of using the turn and position system, patients will be turned according to the standard procedure on the ward.

What is being measured

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

  1. Turning compliance of nurses within the trial period as assessed by the researcher (unannounced)

    The researcher wil collect and administer data about turning compliance and compliance with the protocol

    Measured: within 8 days after the start of the study

Secondary outcomes (6)

  1. Turning angle

    Per patient the researcher will measure two times the turning angle in which the patient is positioned.

    Measured: within 8 days after the start of the study

  2. Sacrum free of pressure

    Per patient the researcher will investigate two times if the sacrum is free of pressure while the patient is positioned.

    Measured: within 8 days after the start of the study

  3. Incidence of pressure ulcers and incontinence-associated dermatitis

    Measured: within 8 days after the start of the study

  4. Comfort and preferences of the caregiver

    Questions on comfort and preferences of the TAP, comfort shield barrier cream cloths and tailored repositioning will be assessed. At baseline these questions will assess the traditional care.

    Measured: On baseline and at day 8 (the end of the study)

  5. Comfort and tolerance of the patient

    Questions on comfort and tolerance of the TAP, comfort shield barrier cream cloths and repositioning will be assessed by the caregiver. At baseline these questions will assess the traditional care.

    Measured: At day 8 (the end of the study)

  6. Cost-effectiveness of the prevention of pressure ulcers

    The following costs will be calculated to provide insight concerning cost-effectiveness:

    Objective time analysis of repositioning (by using a chronometer), Subjective time analysis of repositioning, Daily consumption of comfort shield barrier cream cloths and microclimate body pads

    Measured: For the duration of the study (8 days)

Timeline

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

  1. First posted24 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionDec 2017
  4. Study completionDec 2017

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
None (open label)
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02690753
Sponsor's protocol ID
PA2015/041
Status last verified
Mar 2018
First submitted
8 Dec 2015
Last updated
9 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.

    PubMed 27841440

  • Beeckman D, Van Lancker A, Van Hecke A, Verhaeghe S. A systematic review and meta-analysis of incontinence-associated dermatitis, incontinence, and moisture as risk factors for pressure ulcer development. Res Nurs Health. 2014 Jun;37(3):204-18. doi: 10.1002/nur.21593. Epub 2014 Apr 3.

    PubMed 24700170

  • De Meyer D, Van Hecke A, Verhaeghe S, Beeckman D. PROTECT - Trial: A cluster RCT to study the effectiveness of a repositioning aid and tailored repositioning to increase repositioning compliance. J Adv Nurs. 2019 May;75(5):1085-1098. doi: 10.1111/jan.13932. Epub 2019 Jan 25.

    PubMed 30549321

Questions about this trial

What is this clinical trial studying?

A study testing A protocol tailored to individual risk factors, The Prevalon® Turn and Position System 2.0 and Comfort Shield® barrier cream cloths in people with Pressure Ulcers and Incontinence-associated Dermatitis, run by University Ghent at 15 sites in Belgium.

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 4 inclusion and 1 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Belgium. 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?

Turning compliance of nurses within the trial period as assessed by the researcher (unannounced) (time frame: within 8 days after the start of the study). 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 NCT02690753, which also lists 3 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 9 Mar 2018.

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