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

March 8, 2018 updated by: UCVV, University Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • ASZ Aalst
      • Antwerpen, Belgium
        • AZ Monica
      • Antwerpen, Belgium
        • ZNA Hoge Beuken
      • Antwerpen, Belgium
        • ZNA St. Elisabeth
      • Bonheiden, Belgium
        • Imelda Ziekenhuis
      • Brugge, Belgium
        • AZ St. Jan Brugge
      • Geraardsbergen, Belgium
        • ASZ Geraardsbergen
      • Menen, Belgium
        • AZ Delta Menen
      • Oostende, Belgium
        • AZ St. Jan Oostende
      • Roeselare, Belgium
        • AZ Delta Roeselare
    • Antwerpen
      • Duffel, Antwerpen, Belgium, 2570
        • AZ St. Maarten
      • Geel, Antwerpen, Belgium
        • AZ St. Dimpna
    • Oost-Vlaanderen
      • Beveren, Oost-Vlaanderen, Belgium
        • AZ Nikolaas campus Beveren
      • Gent, Oost-Vlaanderen, Belgium
        • UZ Gent
      • Oudenaarde, Oost-Vlaanderen, Belgium, 9700
        • AZ Oudenaarde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Patients with no active or supportive therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tailored repositioning + Standardised incontinence care + TAP
A 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.
Procedure: A protocol tailored to individual risk factors
Device: The Prevalon® Turn and Position System 2.0
Device: Comfort Shield® barrier cream cloths
Experimental: Standard repositioning + Standardised incontinence care + TAP
Instead 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.
Device: The Prevalon® Turn and Position System 2.0
Device: Comfort Shield® barrier cream cloths
No Intervention: Usual care
Instead 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The researcher wil collect and administer data about turning compliance and compliance with the protocol
within 8 days after the start of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Turning angle
Time Frame: within 8 days after the start of the study
Per patient the researcher will measure two times the turning angle in which the patient is positioned.
within 8 days after the start of the study
Sacrum free of pressure
Time Frame: within 8 days after the start of the study
Per patient the researcher will investigate two times if the sacrum is free of pressure while the patient is positioned.
within 8 days after the start of the study
Incidence of pressure ulcers and incontinence-associated dermatitis
Time Frame: within 8 days after the start of the study
within 8 days after the start of the study
Comfort and preferences of the caregiver
Time Frame: On baseline and at day 8 (the end of the study)
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.
On baseline and at day 8 (the end of the study)
Comfort and tolerance of the patient
Time Frame: At day 8 (the end of the study)
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.
At day 8 (the end of the study)
Cost-effectiveness of the prevention of pressure ulcers
Time Frame: For the duration of the study (8 days)

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
For the duration of the study (8 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

Sage Products, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

February 19, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA2015/041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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