Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000793718
Ethics application status
Approved
Date submitted
30/05/2022
Date registered
6/06/2022
Date last updated
24/01/2023
Date data sharing statement initially provided
6/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing sacral prophylactic dressings: TOWARDS ZERO pilot study
Scientific title
Testing the efficacy of two sacral dressings in preventing pressure injuries(z) in adult intensive care population: TOWARDS ZERO pilot study
Secondary ID [1] 307195 0
None
Universal Trial Number (UTN)
U1111-1278-6055
Trial acronym
Testing the efficacy Of tWo sAcral Dressings in preventing preSsure injuries(Z) in adult intEnsive caRe pOpulation: TOWARDS ZERO pilot study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital-acquired sacral pressure injuries 326419 0
Condition category
Condition code
Skin 323702 323702 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Allevyn Life Sacrum (Smith+Nephew) and usual pressure injury prevention (PIP) care.

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 and monitor its adherence. This will be documented in the study data collection tool. An inbuilt ‘dressing change indicator’ signals when the dressing should be replaced. Dressings will also be changed if 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: participants will remain in the trail for a maximum of 14-days or until a study endpoint is reached: (i) develop a sacral hospital-acquired pressure injury (HAPI) (any stage); (ii) requires more than 6-hours continuous prone positioning; (iii) ICU discharge; (iv) death; (v) urinary/faecal incontinence; (vi) consent withdrawal; whichever comes first.

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] 323642 0
Prevention
Comparator / control treatment
Control: Mepilex® Border Sacrum (Molnlycke®) and usual pressure injury prevention (PIP) care.

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 day and monitor its adherence. This will be documented in the study data collection tool.. 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.

Trial end points: participants will remain in the trail for a maximum of 14-days or until a study endpoint is reached: (i) develop a sacral HAPI (any stage); (ii) requires more than 6-hours continuous prone positioning; (iii) ICU discharge; (iv) death; (v) urinary/faecal incontinence; (vi) consent withdrawal; whichever comes first.

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.
Control group
Active

Outcomes
Primary outcome [1] 331450 0
To evaluate the feasibility of conducting a larger multi-site randomised controlled trial against: • Eligibility: greater than or equal to 50% of screened patients will be eligible for recruitment; • 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 10% of participants will be lost to follow up; and • Missing data: Less than 10% of the data will be missing.
Timepoint [1] 331450 0
Study specific tools will be developed. Each day, a screening and eligibility log will be completed to determine eligibility, recruitment, retention. Protocol fidelity and intervention allocation will be monitored and reported daily using a study specific data collection tool. Data will include, dressing type, dressing applied, dressing intact, dressing removed and reason why. The overall data, including missing data will be monitored weekly throughout the study and at study completion
Secondary outcome [1] 409931 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 [1] 409931 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 [2] 409932 0
Sacral HAPI Stage 2 or greater (Using the international HAPI staging classification system);
Timepoint [2] 409932 0
Daily data collection and at the study completion. Participants will have a daily colour digital photograph taken of their sacrum. A blinded outcome assessor completes the daily assessment to determine the presence of a sacral HAPI. This is completed for a maximum of 14 days or until they reach a trial end point.
Secondary outcome [3] 409933 0
Device deficiencies. This may be either dressing edges rolled or adhesion lost. Measured as counts (frequencies) per patient.. This will be assessed as a composite outcome.
Timepoint [3] 409933 0
Using a study specific data collection tool, data on device deficiencies will be collected each day to a maximum of 14 days or until they reach a trial end point

Eligibility
Key inclusion criteria
Inclusion criteria (all criteria met): (i) 18 years and older; (ii) recruited within 24-hours of ICU admission; (iii) assessed as high pressure injury (PI) risk; (iv) ICU length of stay greater than 24-hours; (v) consent [patient/representative].
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria (one criterion excludes): (i) requires greater than 6-hours continuous prone; (ii) receiving end-of-life care; (iii) conditions preventing repositioning; (iv) previous or current sacral PI; (v) sacral skin injury/condition/allergy; (vi) urinary/faecal incontinence at recruitment; (vii) regular sacral topical creams (e.g. hydrocortisone); (viii) prior to screening, ICU team applied a prophylactic sacral dressing as part of their PIP care.

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 is concealed to the data collector and patient/proxy. Allocation will be determined by an off-site independent web-based randomisation service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
using an independent web-based randomisation service, participants will be randomised in varying block sizes of 2, 4 and 6 to either the intervention or control. Participants will be further stratified into medical and surgical ICU patients.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/01/2023
Actual
16/01/2023
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
14/07/2023
Actual
Sample size
Target
80
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22427 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 37591 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 311500 0
Government body
Name [1] 311500 0
Queensland Department of Health
Country [1] 311500 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Office for Research, 170 Kessels Road, Nathan, Qld, 4111
Country
Australia
Secondary sponsor category [1] 312904 0
None
Name [1] 312904 0
Address [1] 312904 0
Country [1] 312904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310960 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 310960 0
1 Hospital Blvd, Southport, Qld, 4125
Ethics committee country [1] 310960 0
Australia
Date submitted for ethics approval [1] 310960 0
15/06/2022
Approval date [1] 310960 0
22/12/2022
Ethics approval number [1] 310960 0
HREC/2022/QGC/85006

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. Intensive care unit (ICU) patients are among the most vulnerable patients in hospital, placing them at very high risk of developing sacral (tailbone) pressure injuries (PI) or bed sores. PI prolongs hospitalisation for patients and increases healthcare costs. Patients report PI are painful and compromise their quality of life. Several specialised dressings prevent sacral PI however limited effectiveness evidence results in clinicians asking, ‘which dressing is better’? This ICU pilot study will determine the feasibility of launching a larger randomised controlled trial testing two prophylactic sacral dressing and provide clinicians with a definitive answer to inform their practice. The study hypothesis is to evaluate the feasibility of achieving participant recruitment (50% eligible and 70% recruited, with 90% retention), protocol fidelity (95% participants will receive the correct intervention) and less than 10% missing data.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119506 0
Dr Sharon L Latimer
Address 119506 0
Griffith University, School of Nursing and Midwifery, L05 3.44 Logan campus, Meadowbrook, Qld, 4131
Country 119506 0
Australia
Phone 119506 0
+61416104380
Fax 119506 0
Email 119506 0
s.latimer@griffith.edu.au
Contact person for public queries
Name 119507 0
Dr Sharon L Latimer
Address 119507 0
Griffith University, School of Nursing and Midwifery, L05 3.44 Logan campus, Meadowbrook, Qld, 4131
Country 119507 0
Australia
Phone 119507 0
+61416104380
Fax 119507 0
Email 119507 0
s.latimer@griffith.edu.au
Contact person for scientific queries
Name 119508 0
Dr Sharon L Latimer
Address 119508 0
Griffith University, School of Nursing and Midwifery, L05 3.44 Logan campus, Meadowbrook, Qld, 4131
Country 119508 0
Australia
Phone 119508 0
+61416104380
Fax 119508 0
Email 119508 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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.