Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000211167
Ethics application status
Approved
Date submitted
29/01/2019
Date registered
13/02/2019
Date last updated
29/06/2021
Date data sharing statement initially provided
13/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Dressings used over the nasal bridge for patients undergoing Acute Non-Invasive Ventilation therapy: A randomised, controlled non-inferiority trial of two dressings for pressure injury prevention and patient and nurse satisfaction.
Scientific title
Dressings used over the nasal bridge for patients undergoing Acute Non-Invasive Ventilation therapy: A randomised, controlled non-inferiority trial of two dressings for pressure injury prevention and patient and nurse satisfaction.
Secondary ID [1] 297206 0
None
Universal Trial Number (UTN)
U1111-1227-3847
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure Injury Prevention 311252 0
Condition category
Condition code
Skin 309870 309870 0 0
Other skin conditions
Respiratory 309974 309974 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Use of the Mepilex Border Lite™ 4x5cm (Molnlycke) all-in-one thin foam dressing on the nasal bridge of patients undergoing acute non-invasive ventilation therapy in the study setting.
Data will be collected for all patients assigned to the study for the duration of their acute non-invasive ventilation treatment, up to a maximum of 7 days, or until a pressure injury develops.
Dressings will only be changed as required as according to usual practice (Hospital Wound Management Policy); frequency of such changes form part of the data to be collected.
A standardised data collection form will be used to record all data with fidelity, adherence and accuracy of recording checked by a research nurse assistant.
All other standard pressure injury strategies as specified in the International Prevention and Treatment of Pressure Ulcers - Clinical Practice Guidelines (National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance, 2014) will be used as usual by the registered nurse caring for the patient, including the lifting of the dressing to check for pressure injuries.
Intervention code [1] 313458 0
Prevention
Comparator / control treatment
Use of the Comfeel Plus Transparent™ (Coloplast®) hydrocolloid dressing on the nasal bridge of patients undergoing acute non-invasive ventilation therapy in the study setting.
All other cares, including pressure injury strategies will be the same as per usual / standard care as specified in the International Prevention and Treatment of Pressure Ulcers - Clinical Practice Guidelines (National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance, 2014).
Control group
Active

Outcomes
Primary outcome [1] 318820 0
Pressure injury occurrence across the nasal bridge
Timepoint [1] 318820 0
When noted within 7 days post dressing application and as recorded in the patient's medical records and in the hospital incident monitoring database
Primary outcome [2] 319016 0
Stage of initial pressure injury
Timepoint [2] 319016 0
At time of first determination of pressure injury within a 7 day period from application of dressing as noted in the patient's medical records and as recorded in the hospital incident monitoring database. Staging will be according to the 2014 International Pressure Injury Prevention guidelines published by the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance.
Primary outcome [3] 319017 0
Pressure injury stage validation by specifically trained validator nurses
Timepoint [3] 319017 0
Date and time of validation as recorded in the patient's medical records and in the hospital incident monitoring database.
Secondary outcome [1] 366152 0
Nurses experience with dressing utility assessed as a composite outcome as per a 5 point Likert Scale for: Ease of lifting for inspection; Ease of re-application or new application; Conformity – how well did the dressing conform to the nasal bridge.
Timepoint [1] 366152 0
Three times a day for 7 days of study patient participation
Secondary outcome [2] 366153 0
Dressing condition as assessed according to wound dressing policy and International guidelines, as determined with a 3 point Likert scale of very good, medium, poor.
Timepoint [2] 366153 0
Three times a day for 7 days of study patient participation
Secondary outcome [3] 366154 0
Patient satisfaction with dressing assessed as a composite outcome as per a 5 point Likert Scale for comfort for: When dressing is lifted for skin inspection; During dressing re-application or new application; While sleeping; During hygiene; While watching TV; While reading.
Timepoint [3] 366154 0
Daily for seven days of study participation
Secondary outcome [4] 366726 0
Determination of the need for dressing to be replaced as according to wound dressing policy and International guidelines and answered as yes/no and supply of a reason for this determination.
Timepoint [4] 366726 0
Three times a day for 7 days of study patient participation

Eligibility
Key inclusion criteria
Inclusion criteria
• Adults over 18 years
• Fitted with a vented NIV mask for the purpose of non-invasive ventilation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
• Pre-existing nasal bridge pressure injury.
• Documented allergy to adhesives used in the two dressings.
• Patients who refuse to change NIV mask when clinically indicated
• Patients who refuse to wear a nasal bridge dressing under the NIV mask.

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)
Allocation concealment with the use of opaque envelopes containing numbered envelopes containing the next randomisation sequence will be used to blind staff and patients as to which group participants are allocated to prior to consent and prior to dressing application. Once consented and randomised to a study arm, the trial will be open-label (unblinded) as it is impossible to conceal from staff which dressing they are applying, and patients or relatives will be able to know/ask once the dressing is opened and applied.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator will be used to allocate participants (1:1) to one of the two nasal bridge dressing groups. The randomisation will be achieved using opaque numbered envelopes containing the next randomisation sequence. Participants will be allocated to a study group based on the results of the next numbered randomisation envelope available on the NIV trolley.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be entered manually into SPSS (version 25) for analysis. Descriptive statistics will be used to summarise the data e.g. means and percentages. Parametric tests (provided data assumptions are met) will be used to analyse differences and relationships between variables. Significance will be set at p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
27/01/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
118
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12985 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 25465 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 301756 0
Hospital
Name [1] 301756 0
The Prince Charles Hospital
Country [1] 301756 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
The Prince Charles Hospital
Rode Road, Chermside
QLD Australia 4032
Country
Australia
Secondary sponsor category [1] 301500 0
None
Name [1] 301500 0
Address [1] 301500 0
Country [1] 301500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302477 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 302477 0
Ethics committee country [1] 302477 0
Australia
Date submitted for ethics approval [1] 302477 0
01/03/2019
Approval date [1] 302477 0
23/10/2019
Ethics approval number [1] 302477 0
Project ID: 50438

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

Contacts
Principal investigator
Name 90354 0
Prof Paul Fulbrook
Address 90354 0
Level 5, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, QLD 4032
Country 90354 0
Australia
Phone 90354 0
+61 7 3139 4087
Fax 90354 0
Email 90354 0
[email protected]
Contact person for public queries
Name 90355 0
Paul Fulbrook
Address 90355 0
Level 5, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, QLD 4032
Country 90355 0
Australia
Phone 90355 0
+61 7 3139 4087
Fax 90355 0
Email 90355 0
[email protected]
Contact person for scientific queries
Name 90356 0
Paul Fulbrook
Address 90356 0
Level 5, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, QLD 4032
Country 90356 0
Australia
Phone 90356 0
+61 7 3139 4087
Fax 90356 0
Email 90356 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.