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

Primary Purpose

Pressure Ulcers, Incontinence-associated Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
A protocol tailored to individual risk factors
The Prevalon® Turn and Position System 2.0
Comfort Shield® barrier cream cloths
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcers focused on measuring Repositioning, Incontinence care, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AZ St. Maarten
  • AZ St. Dimpna
  • AZ Nikolaas campus Beveren
  • UZ Gent
  • AZ Oudenaarde
  • ASZ Aalst
  • AZ Monica
  • ZNA Hoge Beuken
  • ZNA St. Elisabeth
  • Imelda Ziekenhuis
  • AZ St. Jan Brugge
  • ASZ Geraardsbergen
  • AZ Delta Menen
  • AZ St. Jan Oostende
  • AZ Delta Roeselare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Tailored repositioning + Standardised incontinence care + TAP

Standard repositioning + Standardised incontinence care + TAP

Usual care

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Turning angle
Per patient the researcher will measure two times the turning angle in which the patient is positioned.
Sacrum free of pressure
Per patient the researcher will investigate two times if the sacrum is free of pressure while the patient is positioned.
Incidence of pressure ulcers and incontinence-associated dermatitis
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.
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.
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

Full Information

First Posted
December 8, 2015
Last Updated
March 8, 2018
Sponsor
University Ghent
Collaborators
Sage Products, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02690753
Brief Title
Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Ghent
Collaborators
Sage Products, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers, Incontinence-associated Dermatitis
Keywords
Repositioning, Incontinence care, Prevention

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Tailored repositioning + Standardised incontinence care + TAP
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard repositioning + Standardised incontinence care + TAP
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
A protocol tailored to individual risk factors
Intervention Type
Device
Intervention Name(s)
The Prevalon® Turn and Position System 2.0
Intervention Type
Device
Intervention Name(s)
Comfort Shield® barrier cream cloths
Primary Outcome Measure Information:
Title
Turning compliance of nurses within the trial period as assessed by the researcher (unannounced)
Description
The researcher wil collect and administer data about turning compliance and compliance with the protocol
Time Frame
within 8 days after the start of the study
Secondary Outcome Measure Information:
Title
Turning angle
Description
Per patient the researcher will measure two times the turning angle in which the patient is positioned.
Time Frame
within 8 days after the start of the study
Title
Sacrum free of pressure
Description
Per patient the researcher will investigate two times if the sacrum is free of pressure while the patient is positioned.
Time Frame
within 8 days after the start of the study
Title
Incidence of pressure ulcers and incontinence-associated dermatitis
Time Frame
within 8 days after the start of the study
Title
Comfort and preferences of the caregiver
Description
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.
Time Frame
On baseline and at day 8 (the end of the study)
Title
Comfort and tolerance of the patient
Description
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.
Time Frame
At day 8 (the end of the study)
Title
Cost-effectiveness of the prevention of pressure ulcers
Description
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
Time Frame
For the duration of the study (8 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Beeckman, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ St. Maarten
City
Duffel
State/Province
Antwerpen
ZIP/Postal Code
2570
Country
Belgium
Facility Name
AZ St. Dimpna
City
Geel
State/Province
Antwerpen
Country
Belgium
Facility Name
AZ Nikolaas campus Beveren
City
Beveren
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
AZ Oudenaarde
City
Oudenaarde
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9700
Country
Belgium
Facility Name
ASZ Aalst
City
Aalst
Country
Belgium
Facility Name
AZ Monica
City
Antwerpen
Country
Belgium
Facility Name
ZNA Hoge Beuken
City
Antwerpen
Country
Belgium
Facility Name
ZNA St. Elisabeth
City
Antwerpen
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
Country
Belgium
Facility Name
AZ St. Jan Brugge
City
Brugge
Country
Belgium
Facility Name
ASZ Geraardsbergen
City
Geraardsbergen
Country
Belgium
Facility Name
AZ Delta Menen
City
Menen
Country
Belgium
Facility Name
AZ St. Jan Oostende
City
Oostende
Country
Belgium
Facility Name
AZ Delta Roeselare
City
Roeselare
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
27841440
Citation
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.
Results Reference
background
PubMed Identifier
24700170
Citation
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.
Results Reference
background
PubMed Identifier
30549321
Citation
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.
Results Reference
derived
Links:
URL
http://www.ucvvgent.be
Description
Website of the research group

Learn more about this trial

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

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