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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
4/02/2019
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
Scientific title
A randomised controlled trial of a turning and positioning system for the prevention of pressure injuries in the Intensive Care Unit
Secondary ID [1] 296650 0
Nil Known
Universal Trial Number (UTN)
Nil Known
Trial acronym
TaP ICU
Linked study record
Nil Known

Health condition
Health condition(s) or problem(s) studied:
Pressure injuries 310474 0
Condition category
Condition code
Skin 309188 309188 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 312955 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 308165 0
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:
Timepoint [1] 308165 0
ICU discharge
Secondary outcome [1] 354121 0
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.
Timepoint [1] 354121 0
ICU discharge

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).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12443 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 24718 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 301228 0
University
Name [1] 301228 0
The University of Melbourne
Address [1] 301228 0
The University of Melbourne. 161 Barry Street, Parkville 3010 Victoria Australia.
Country [1] 301228 0
Australia
Funding source category [2] 301833 0
Commercial sector/Industry
Name [2] 301833 0
Molnlycke Healthcare.
Address [2] 301833 0
Gamlestadsvägen 3c, P.O. Box 130 80 SE-402 53 Gothenburg
Country [2] 301833 0
Sweden
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne. 161 Barry Street, Parkville 3010 Victoria Australia.
Country
Australia
Secondary sponsor category [1] 300862 0
Hospital
Name [1] 300862 0
Ther Northern Hospital
Address [1] 300862 0
185 Cooper Street Epping 3076 Victoria Australia.
Country [1] 300862 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301971 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 301971 0
145 Study Road Heidelberg 3084 Victoria Australia
Ethics committee country [1] 301971 0
Australia
Date submitted for ethics approval [1] 301971 0
26/11/2018
Approval date [1] 301971 0
10/01/2019
Ethics approval number [1] 301971 0
HREC/48469/Austin-2018

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88718 0
Dr Suzanne Kapp
Address 88718 0
The University of Melbourne. 161 Barry Street Parkville 3010 Victoria Australia.
Country 88718 0
Australia
Phone 88718 0
+61 0412972106
Fax 88718 0
Email 88718 0
suzanne.kapp@unimelb.edu.au
Contact person for public queries
Name 88719 0
Dr Suzanne Kapp
Address 88719 0
The University of Melbourne. 161 Barry Street Parkville 3010 Victoria Australia.
Country 88719 0
Australia
Phone 88719 0
+61 0412972106
Fax 88719 0
Email 88719 0
suzanne.kapp@unimelb.edu.au
Contact person for scientific queries
Name 88720 0
Dr Suzanne Kapp
Address 88720 0
The University of Melbourne. 161 Barry Street Parkville 3010 Victoria Australia.
Country 88720 0
Australia
Phone 88720 0
+61 0412972106
Fax 88720 0
Email 88720 0
suzanne.kapp@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No approval to share individual participant data.
What supporting documents are/will be available?
Study protocol
Summary results
No Results