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Trial registered on ANZCTR
Registration number
ACTRN12619000156189
Ethics application status
Approved
Date submitted
14/01/2019
Date registered
4/02/2019
Date last updated
21/01/2020
Date data sharing statement initially provided
4/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised controlled trial of a turning and positioning system for the prevention of pressure injuries in the Intensive Care Unit
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Scientific title
A randomised controlled trial of a turning and positioning system for the prevention of pressure injuries in the Intensive Care Unit
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Secondary ID [1]
296650
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Nil Known
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Universal Trial Number (UTN)
Nil Known
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Trial acronym
TaP ICU
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Linked study record
Nil Known
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Health condition
Health condition(s) or problem(s) studied:
Pressure injuries
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Condition category
Condition code
Skin
309188
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Mölnlycke® Tortoise Turning and Positioning System.
This system is comprised of two devices, a Turning Pad and a Fluidized Positioner. The Turning Pad is used to position people in bed (move them up and down the bed, across the bed and to roll them over). The Fluidized Positioner is used to support the body while in bed, in this study propped behind the back when the patient is laying in the side lying lateral position.
The turning pad is made of nylon, polyester, polyurethane and cotton. The fluidized positioner is comprised of a polyurethane (a common type of plastic) bag which contains predominantly Polydimethylsiloxane (a viscous fluid mix).
The Turning and Positioning System may be used by nurses, personal care workers, physiotherapists and doctors. In this study the Turning and Positioning System will be used by nurses and ward support staff (of the Intensive Care Unit at The Northern Hospital) who are involved in the turning and positioning of patients. Patients are typically turned and positioned every 2-4 hours.
The Turning and Positioning System will be used for the duration of the participants stay in the ICU, which is on average 2 days. The system will be in use at all times when the participant is in bed.
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Intervention code [1]
312955
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Prevention
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Comparator / control treatment
Pillows and slide sheets.
The slide sheet is used to position people in bed (move them up and down the bed, across the bed and to roll them over). The pillow is used to support the body while in bed, in this study propped behind the back when the patient is laying in the side lying lateral position.
The slide sheet is made of of slippery sailcloth material and is typically a minimum of two meters in length and one and a half meters wide. The pillows are comprised of a foam or synthetic inner filling which is encased by a stitched or welded impermeable cover made of polyester, vinyl, plastic or Polyvinyl chloride (PVC). Pillows are typically covered with a linen pillow slip.
The slide sheet and pillows may be used by nurses, personal care workers, physiotherapists and doctors. In this study the slide sheet and pillows will be used by nurses and ward support staff (of the Intensive Care Unit at The Northern Hospital) who are involved in the turning and positioning of patients. Patients are typically turned and positioned every 2-4 hours.
The pillow and slide sheet will be used for the duration of the participants stay in the ICU, which is on average 2 days. The pillow and slide sheet will be in use at all times when the participant is in bed.
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Control group
Active
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Outcomes
Primary outcome [1]
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The incidence of pressure injuries expressed as the total number of pressure injuries developed in both intervention and control groups during the study period. Pressure injuries will be classified according to the international guidelines published by the National Pressure Ulcer Advisory Panel and the European Pressure Ulcer Advisory panel (National Pressure Ulcer Advisory Panel, Panel, et al., 2014).
National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, & Pan Pacific Pressure Injury Alliance. (2014). Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Retrieved from Osborne Park, Australia:
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Assessment method [1]
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Timepoint [1]
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ICU discharge
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Secondary outcome [1]
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The marginal cost associated with the use of the turning and positioning system in the intervention group, the treatment costs of pressure injuries in both groups and the average costs per person in both groups.
The cost-benefit analysis will be conducted from a health care sector’s perspective. Only the within-trial cost including the hospital resources and time used to provide pressure injury care by hospital health professionals will be considered. A bottom-up approach will be used to calculate pressure injury prevention and treatment costs by directly tracing the actual use of personnel and resources.
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Assessment method [1]
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Timepoint [1]
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ICU discharge
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Eligibility
Key inclusion criteria
The inclusion criteria are:
• >18 years of age
• ICU admission for critical illness or trauma
• High risk of pressure injury development (a score of <12) according to the Braden Scale for Predicting Pressure Sore Risk (Bergstrom, Braden, Laguzza, & Holman, 1987).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
The exclusion criteria are:
• Has a sacral, ischial tuberosity or buttock pressure injury
• Trauma to sacrum, ischial tuberosity or buttock
• Suspected or actual spinal injury precluding the patient being turned or requiring immobilization
• Has injuries that are not survivable or is receiving palliation
• Known sensitivity to nylon, polyester, polyurethane or cotton.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The analysis will be based on intention to treat (ITT) protocol (Schulz K, Altman D, & D, 2010). The development of pressure injuries per group and pressure injuries by anatomical site per group will be compared using Fishers Exact test. A survival analysis will be used to determine the difference in pressure injury incidence development rates per group and time to provide a hazard ratio (HR) between the groups.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
4/03/2019
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Actual
14/08/2019
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Date of last participant enrolment
Anticipated
30/08/2020
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Actual
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Date of last data collection
Anticipated
6/09/2020
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Actual
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Sample size
Target
430
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Accrual to date
37
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Northern Hospital - Epping
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Recruitment postcode(s) [1]
24718
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3076 - Epping
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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The University of Melbourne
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Address [1]
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The University of Melbourne. 161 Barry Street, Parkville 3010 Victoria Australia.
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Country [1]
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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Molnlycke Healthcare.
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Address [2]
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Gamlestadsvägen 3c, P.O. Box 130 80 SE-402 53 Gothenburg
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Country [2]
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Sweden
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Primary sponsor type
University
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Name
The University of Melbourne
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Address
The University of Melbourne. 161 Barry Street, Parkville 3010 Victoria Australia.
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Ther Northern Hospital
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Address [1]
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185 Cooper Street Epping 3076 Victoria Australia.
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Country [1]
300862
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
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145 Study Road Heidelberg 3084 Victoria Australia
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/11/2018
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Approval date [1]
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10/01/2019
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Ethics approval number [1]
301971
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HREC/48469/Austin-2018
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Summary
Brief summary
The aim of the study is to determine the clinical effectiveness of a system for turning and positioning Intensive Care Unit (ICU) patients, when compared to usual care turning and positioning devices, for preventing pressure injuries.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Suzanne Kapp
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Address
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The University of Melbourne. 161 Barry Street Parkville 3010 Victoria Australia.
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Country
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Australia
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Phone
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+61 0412972106
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Suzanne Kapp
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Address
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The University of Melbourne. 161 Barry Street Parkville 3010 Victoria Australia.
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Country
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Australia
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Phone
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+61 0412972106
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Suzanne Kapp
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Address
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The University of Melbourne. 161 Barry Street Parkville 3010 Victoria Australia.
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Country
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Australia
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Phone
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+61 0412972106
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Fax
88720
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No approval to share individual participant data.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
3858
Basic results
No
376415-(Uploaded-05-04-2023-09-44-08)-Basic results summary.pdf
4106
Plain language summary
No
Pressure injuries (or bed sores) affect 13.1% to 4...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Clinical and cost effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for the prevention of hospital-acquired pressure injuries. A randomised controlled trial.
2023
https://dx.doi.org/10.1111/iwj.14230
N.B. These documents automatically identified may not have been verified by the study sponsor.
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