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Trial registered on ANZCTR


Registration number
ACTRN12620000875909p
Ethics application status
Submitted, not yet approved
Date submitted
1/06/2020
Date registered
2/09/2020
Date last updated
2/09/2020
Date data sharing statement initially provided
2/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing sacral dressings to prevent pressure injuries in adult intensive care unit patients
Scientific title
Prophylactic sacral dressings to prevent hospital-acquired pressure injuries in adult intensive care unit patients: A three-arm pilot randomised controlled trial
Secondary ID [1] 301109 0
Nil
Universal Trial Number (UTN)
U1111-1252-8897
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital-acquired sacral pressure injuries 317703 0
Condition category
Condition code
Skin 315781 315781 0 0
Other skin conditions
Injuries and Accidents 315947 315947 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
*Arm 1: Mepilex® Border Sacrum (Molnlycke®) (dressing 1), sacral Sub-epidermal moisture
(SEM) scanner and usual pressure injury prevention (PIP) care (Intervention 1);
*Arm 2: Allevyn Life Sacrum (Smith+Nephew) (dressing 2), sacral SEM scanner and usual PIP care (Intervention 2);

Dressing 1: involves the Research Nurse applying the Mepilex® Border dressing to the patient's sacrum on study recruitment and changed as per the manufacturer's recommendations. The Research Nurse will check the dressing each day. The manufacturer recommends the dressing is changed when the edge begins to roll and lose adhesion or it becomes soiled. Dressings will also be changed if saturation of the dressing occurs, staff accidentally remove the dressing or if the dressing becomes dislodged. The dressing will be removed when the patient reaches any of the trial end points.


Dressing 2: involves the Research Nurse applying the Allevyn Life Sacrum (Smith + Nephew) dressing to the patient's sacrum on study recruitment and changed as per the manufacturer's recommendations. The Research Nurse will check the dressing each day. An inbuilt ‘dressing change indicator’ signals when the dressing should be replaced. Dressings will also be changed saturation and soiling of the dressing occurs, if the adhesive edges ‘roll’, staff accidentally remove the dressing or if the dressing becomes dislodged. The dressing will be removed when the patient reaches any of the trial end points.
Trial end points and study exit:
• Develop sacral Hospital-acquired pressure injury (HAPI) (any stage);
• Commence prone positioning;
• Require droplet precautions;
• Discharged from ICU;
• Die;
• Develop faecal/urinary incontinence, – whichever occurs first.


SEM Scanner: on recruitment and each data collection day, the Research Nurse will 'peel back' the dressing, take a digital photograph of the sacrum and undertake a non-invasive scan of the sacral skin using a SEM scanner.

Usual PIP care includes regular skin inspection and assessment, second hourly repositioning, elevating heels off the bed, pressure relieving heel boots, and use of pressure redistributing mattresses.
Intervention code [1] 317734 0
Prevention
Comparator / control treatment
*Arm 3: Usual PIP care and sacral SEM scanner only (Control).

Usual PIP care includes regular skin inspection and assessment, second hourly repositioning, elevating heels off the bed, pressure relieving heel boots, and use of pressure redistributing mattresses.

SEM Scanner: on recruitment and each data collection day, the Research Nurse will 'peel back' the dressing, take a digital photograph of the sacrum and undertake a non-invasive scan of the sacral skin using a SEM scanner.
Control group
Active

Outcomes
Primary outcome [1] 323989 0
To evaluate the study protocol feasibility of conducting a larger multi-site randomised controlled trial using pre-defined criteria for participant recruitment and retention, data management, resource allocation and intervention fidelity. The following protocol criteria regarding the recruitment and retention process will be assessed by collecting the following data using a study-specific tool :
• Eligibility: greater than or equal to 50% of screened patients will be eligible for recruitment ( using the inclusion and exclusion criteria);
• Recruitment: greater than or equal to 70% of eligible participants will agree to participate;
• Protocol fidelity: greater than or equal to 95% of participants in the intervention groups will receive their allocated intervention;
• Retention: Less than 15% of participants will be lost to follow up; and
• Missing data: Less than 10% of the data will be missing.
Timepoint [1] 323989 0
Weekly throughout the study and at study completion
Primary outcome [2] 324991 0
'The feasibility of collecting sacral SEM scanner data will be conducted. Assessment, using a study-specific tool, will include data collected on time to complete the measurement.
Timepoint [2] 324991 0
Daily data collection and at the study completion
Secondary outcome [1] 384410 0
The stage of sacral all new hospital-acquired pressure injury (HAPI): A daily digital colour photograph will be taken of each participants sacrum (control and intervention group). Using the international PI staging classification system and a study-specific data collection tool, the blinded outcome assessor will visually determine if a new HAPI has developed, including its stage and severity.
Timepoint [1] 384410 0
Participants will have a daily colour digital photograph taken of their sacrum with the blinded assessment completed daily for a maximum of 14 days or until they reach a trial end point.
Secondary outcome [2] 384411 0
The feasibility of completing a blinded outcome (HAPI) assessment via photography including inter-rater reliability of the assessment. Using a study-specific tool, data will be collected on the time taken to complete the assessment, fidelity of the photograph uploading process, and rater reliability of the assessment (HAPI).
Timepoint [2] 384411 0
Participants will be assessed on recruitment and each day for a maximum of 14 days or until they reach a trial end point.
Secondary outcome [3] 384412 0
Preliminary cost-effectiveness evaluation of the dressings and standard PIP care will be assessed by gathering data using a study specific data collection tool.. Data will include the number of prophylactic dressings applied and the number of pressure injury prevention strategies implemented during the study.
Timepoint [3] 384412 0
Data collection will occur on recruitment and each day to a maximum of 14 days or until they reach a trial end point
Secondary outcome [4] 384413 0
The cumulative sacral Hospital-acquired pressure injury (HAPI) incidence rate of any stage; defined as the number of study participants who develop a sacral HAPI per 1000 patient days. This data will be collected using a study-specific tool.
Timepoint [4] 384413 0
Data collection will occur on recruitment and each day to a maximum of 14 days or until they reach a trial end point

Eligibility
Key inclusion criteria
*Aged 18 years and older;
*Assessed by Intensive Care Unit staff as being at high-risk for Pressure Injury (Research Nurse to confirm eligibility using Waterlow score equal to or greater than 15 AND Braden scale score equal to or less than 13);
*Anticipated Intensive Care Unit length of stay of 48 hours and longer;
*Study recruitment occurs within the first 24-hours of the patient’s Intensive Care Unit admission
*Patient, or their nominated proxy, can provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Patient requiring prolonged prone positioning as part of their ongoing care;
*Patients receiving end-of-life or terminal care;
*Patients requiring droplet infection control precautions such as patients with COVID-19 infections;
*Any clinical condition that prevents the patient from being turned as determined by the Intensive Care Unit team;
*Pre-existing sacral Pressure Injury or other injury/skin condition/allergy;
*Urinary or faecal incontinence at the time of recruitment;
*Prescribed sacral topical cream that reduces dressing adherence;
*Unable to speak or understand English without a hospital interpreter present.

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)
Group allocation will be concealed by using a central randomisation service website to obtain an online code for random allocation of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into one of the three study arms: stratified by medical or surgical ICU patient and in varying block sizes of 3, 6 and 9
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Pilot randomised controlled trial
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All patients’ data will be analysed using intention-to-treat, regardless of the treatment received. Per protocol analysis will be carried out only as a sensitivity analysis. Descriptive results will be reported using summary statistics, depending on the level and distribution of the data. Continuous/interval data will be expressed as mean ± standard deviation or median ± interquartile range based on normality of data and categorical data will be presented as counts and percentages. Inferential statistics, i.e., multivariate logistic regression, controlling for various risk factors will determine if daily sacral SEM results are different between patients with and without pressure injuries.

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)
QLD
Recruitment hospital [1] 16820 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 30443 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 305554 0
University
Name [1] 305554 0
Griffith University MHIQ funding
Address [1] 305554 0
Griffith University, Gold Coast campus,
1 Parklands Dr, Southport QLD 4215
Country [1] 305554 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University, Gold Coast campus,
1 Parklands Dr, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 306308 0
None
Name [1] 306308 0
Address [1] 306308 0
Country [1] 306308 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305861 0
Gold Coast Hospital and Health Service
Ethics committee address [1] 305861 0
1 Hospital Blvd,
Southport, Qld, 4125
Ethics committee country [1] 305861 0
Australia
Date submitted for ethics approval [1] 305861 0
05/06/2020
Approval date [1] 305861 0
Ethics approval number [1] 305861 0

Summary
Brief summary
A pressure injury, or pressure ulcer, is localised damage to the skin and/or underlying tissue caused by unrelieved pressure, shear or friction. Some hospital patients develop pressure injuries- with those in intensive care units at increased risk because they are critically ill and immobile.
Several strategies are recommended in the international clinical practice guidelines for the prevention of pressure injuries. One strategy is the use of prophylactic foam dressings to prevent sacral pressure injuries, yet it remains unclear if these dressings prevent pressure injuries. More recently, sub-epidermal moisture scanners, which detect the early tissue damage associated with pressure injuries, are used by some clinicians during their daily patient skin assessment. A benefit for clinicians is they can use the scanner measurements to implement early and targeted pressure injury prevention strategies before skin redness is visible to the naked eye.
The aim of this pilot study is to determine the feasibility of conducting a larger three-arm randomised controlled trial that will test the effectiveness of two different prophylactic foam dressings, sub-epidermal moisture scanners versus usual care to prevent sacral pressure injuries in adult intensive care patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101842 0
Dr Sharon Latimer
Address 101842 0
Griffith University,
Logan campus,
L05 3.44
University Drive,
Meadowbrook, Qld, 4131
Country 101842 0
Australia
Phone 101842 0
+61416104380
Fax 101842 0
Email 101842 0
s.latimer@griffith.edu.au
Contact person for public queries
Name 101843 0
Dr Sharon Latimer
Address 101843 0
Griffith University,
Logan campus,
L05 3.44
University Drive,
Meadowbrook, Qld, 4131
Country 101843 0
Australia
Phone 101843 0
+61416104380
Fax 101843 0
Email 101843 0
s.latimer@griffith.edu.au
Contact person for scientific queries
Name 101844 0
Dr Sharon Latimer
Address 101844 0
Griffith University,
Logan campus,
L05 3.44
University Drive,
Meadowbrook, Qld, 4131
Country 101844 0
Australia
Phone 101844 0
+61416104380
Fax 101844 0
Email 101844 0
s.latimer@griffith.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 plans to share individual participant data.
What supporting documents are/will be available?
No other documents available
Summary results
No Results