Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001072808
Ethics application status
Approved
Date submitted
19/04/2021
Date registered
13/08/2021
Date last updated
4/10/2024
Date data sharing statement initially provided
13/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of using hyperoxygenated fatty acids (HOFA) to prevent facial pressure injuries from medical devices. This change occurred before the recruitment of study participants.
Scientific title
A randomised controlled phase II trial to examine the feasibility of using hyperoxygenated fatty acids (HOFA) to prevent facial pressure injuries from medical devices among adults admitted to intensive care – a research protocol.
Secondary ID [1] 303961 0
nil
Universal Trial Number (UTN)

UTN :-U1111-1267-6202
Trial acronym
HOFA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Pressure Injuries 321577 0
Condition category
Condition code
Injuries and Accidents 319317 319317 0 0
Other injuries and accidents
Public Health 319924 319924 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The source population for the feasibility study will be adults admitted to ICU, with facial medical devices (CPAP, BiPAP, ETT, NGT, Nasal prongs, High-flow nasal prongs) as part of their current treatment. The source population for the staff survey and focus groups will be clinical nursing staff from the four ICUs. This study will be undertaken among the Intensive Care population who are expected to be admitted for more than 24 hours. All conscious patients with facial medical devices will be approached to participate in the study. All unconscious patients families with facial medical devices will be approached to participate in the study.

The Hyperoxygenated Fatty Acids are wiped onto the participants skin via a swab (similar to an alcohol swab). The HOFA will be applied to areas of the face where medical devices contact the skin. This intervention will be applied once per shift by the individual Registered Nurse (RNs) who is responsible for the patient, the RN will assess at the time of usual care being undertaken every 4 hours. As part of routine nursing care, each study participant will have a skin assessment, that includes the neck, head, and face. This assessment included the classification of the skin as a normal colour, red (blanchable and non-blanchable), and staging of any pressure injuries using NPUAP/EPUAP classification system. This change occurred before the recruitment of study participants.
Intervention code [1] 320303 0
Prevention
Intervention code [2] 320304 0
Treatment: Devices
Comparator / control treatment
The use of HOFA is being compared to usual preventative measures undertaken. Comfeel is the usual preventative measure. Comfeel is applied to areas where the device comes into contact with the skin. When a facial device is placed onto the patient and remains insitu for the time the facial medical device is insitu.
Control group
Active

Outcomes
Primary outcome [1] 327213 0
Development of pressure injuries secondary to use of facial medical devices will be determined by visual assessment by nursing staff using the Waterlow assessment
Timepoint [1] 327213 0
on discharge from ICU and follow up 14 days post discharge.
Primary outcome [2] 327800 0
Pain assessed using the Numeric Pain Rating Scale 1-10.
Timepoint [2] 327800 0
From time of admission to study to discharge from ICU
Primary outcome [3] 327801 0
Overall length of hospital stay will be assessed by data-linkage to medical records
Timepoint [3] 327801 0
at discharge from hospital, medical record review.
Secondary outcome [1] 394254 0
Any change in costs associated with the management of pressure injuries (e.g. wound dressings, analgesia, antibiotics and surgery for extreme cases and engagement with Primary Health Care services.) This will be determined by comparing costs of wound management, antibiotics associated with wound management, surgery and PHC between the patient groups.
Timepoint [1] 394254 0
At the conclusion of the study
Secondary outcome [2] 397859 0
Acceptability composite outcome measured by assessing 1. behaviour (amount of swabs used ), 2. perceptions about the product and its impact on patients. Via online survey and focus groups.
Timepoint [2] 397859 0
Survey staff via online survey and focus groups at the completion of the trial.
Secondary outcome [3] 397860 0
Feasibility composite outcomes measured by assessing adherence to the study, recruitment to the study and number of eligible participants. These data will be determined from an audit of patient medical records, review of IIMS, study enrolment logs.
Timepoint [3] 397860 0
At completion of data collection
Secondary outcome [4] 397861 0
Sustainability composite outcome measured by assessing, product use, cost, audit of adherence to intervention, infection rates, rates of PI secondary to facial medical devices, length of stay in ICU. These data will be determined by measuring the amount of product used, data-linking to hospital financial records, review of patients medical records, review of IIMS.
Timepoint [4] 397861 0
At 3 and 6 months measurement of the amount of product used, data-linking to hospital financial records, review of patients medical records, review of IIMS.

Eligibility
Key inclusion criteria
All adult patients in Intensive Care with facial medical devices (CPAP, BiPAP, ETT, NGT, Nasal prongs, High-flow nasal prongs) as part of their current treatment are eligible to participate in the trial.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patient who does not have a medical facial device implemented as part of their current treatment.
Patients with significant traumatic facial injuries, burns or facial surgery where Hyperoxygenated Fatty Acids are deemed contraindicated.
Patients who at the end-of-life, or are not expected to stay in the ICU for at least 24-hours.

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)
Centrally randomised by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study participants will be blocked randomised (permuted blocks of 4-6 within study sites, with concealment being maintained by using the randomisation function in REDCap to reduce bias and achieve balance in the participant treatment arm of the study. This change occurred before the recruitment of study participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis of the effectiveness of HOFA to prevent facial pressure injuries will be undertaken using an intension-to-treat approach and as per protocol analysis. Rates of FPI will be compared between the HOFA and usual care groups using Cox’s Proportional Hazards model, to incorporate exposure time at-risk to medical devices in the ICU (Cox, 1972). Interim analysis for superiority or inferiority will be undertaken by an external group, using an alpha spending function (Pocock, 1977), with upper and lower cut-off being based of the method suggested by O’Brien and Fleming (O'Brien and Fleming, 1979). For example, at the first planned interim analysis of 170 enrolled study participants (permuted block), the upper and lower z-score cut-offs for superiority or inferiority are 3.47 (one-sided p-value of 0.0003), and subsequent z-score cut-offs are presented in the figure below (2nd interim z-score of 2.45, one-sided p -value = 0.0069, and final analysis, z-score of 2, one-sided p -value = 0.0178):

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
12/08/2024
Date of last participant enrolment
Anticipated
11/08/2025
Actual
Date of last data collection
Anticipated
25/08/2025
Actual
Sample size
Target
197
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19152 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 19153 0
Fairfield Hospital - Prairiewood
Recruitment hospital [3] 19154 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 19156 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 33714 0
2170 - Liverpool
Recruitment postcode(s) [2] 33715 0
2176 - Prairiewood
Recruitment postcode(s) [3] 33716 0
2560 - Campbelltown
Recruitment postcode(s) [4] 33718 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 308341 0
University
Name [1] 308341 0
Western Sydney University
Country [1] 308341 0
Australia
Funding source category [2] 308813 0
Government body
Name [2] 308813 0
South West Sydney Local Health District
Country [2] 308813 0
Australia
Primary sponsor type
Individual
Name
Leanne Hunt
Address
Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
Country
Australia
Secondary sponsor category [1] 309157 0
Individual
Name [1] 309157 0
Steve Frost
Address [1] 309157 0
South West Sydney local health district (Liverpool)
Locked Bag 7103
Liverpool BC NSW 1871
Country [1] 309157 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308315 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 308315 0
Ethics committee country [1] 308315 0
Australia
Date submitted for ethics approval [1] 308315 0
08/01/2021
Approval date [1] 308315 0
12/11/2021
Ethics approval number [1] 308315 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110278 0
Dr Leanne Hunt
Address 110278 0
Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
Country 110278 0
Australia
Phone 110278 0
+61 2 45701676
Fax 110278 0
+61 2 4570 1420
Email 110278 0
[email protected]
Contact person for public queries
Name 110279 0
Leanne Hunt
Address 110279 0
Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
Country 110279 0
Australia
Phone 110279 0
+61 2 45701676
Fax 110279 0
+61 2 4570 1420
Email 110279 0
[email protected]
Contact person for scientific queries
Name 110280 0
Steven Frost
Address 110280 0
South West Sydney Local Health District (Liverpool)
Locked Bag 7103
Liverpool BC NSW 1871
Country 110280 0
Australia
Phone 110280 0
+61 2 8739360
Fax 110280 0
61 02 8738 9206
Email 110280 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.