Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001012864
Ethics application status
Approved
Date submitted
9/06/2021
Date registered
2/08/2021
Date last updated
19/10/2023
Date data sharing statement initially provided
2/08/2021
Date results information initially provided
19/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Securing jugular central venous catheters with dressings fixed to a liquid adhesive (Mastisol) in an Intensive Care Unit population: a randomised controlled trial re-thinking evidence-based care delivery
Scientific title
Effect of securing jugular central venous catheters with dressings fixed to a liquid adhesive (Mastisol) on dressing failure in an Intensive Care Unit population: a randomised controlled trial re-thinking evidence-based care delivery
Secondary ID [1] 303912 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
STICKY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous catheter dressing and securement 321495 0
Condition category
Condition code
Anaesthesiology 319249 319249 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mastisol liquid adhesive (MLA) in addition to 'standard' central venous catheter dressing and securement products as per hospital policy. MLA will be applied to the skin around the CVC insertion site as per manufacturer’s instructions after skin decontamination and securement placement (if used) and before dressing application.
At each CVC dressing change, existing MLA will be removed using adhesive remover wipes and re-applied by the bedside nurse/clinician at every CVC dressing change for the duration of the CVC dwell.
Participants and their dressings will be inspected daily by the research team to monitor dressing adherence and adverse events.
In a subset of participants (convenience sample), skin swabs will be taken by research staff to assess skin flora at the CVC insertion sites at the time of CVC removal.
Intervention code [1] 320217 0
Prevention
Comparator / control treatment
'Standard' central venous catheter dressing and securement products (as per hospital policy)
Control group
Active

Outcomes
Primary outcome [1] 327125 0
'Dressing failure' defined as requirement for initial internal jugular central venous catheter dressing to be replaced due to the dressing lifting at the edges, prior to scheduled dressing change (scheduled dressing changes are every 7 days). This outcome will be assessed through daily visualisation of the dressing, and notes from the patient's medical records.
Timepoint [1] 327125 0
From time of central venous catheter (CVC) insertion to CVC removal.
Secondary outcome [1] 393870 0
'All-cause central venous catheter failure' defined as a composite of failure resulting from pain, infiltration/extravasation, blockage/occlusion (with or without leakage), fracture, thrombosis, dislodgement (complete or partial), or haematoma.
This outcome will be assessed through daily visualisation of the CVC, and notes from the patient's medical records.
Timepoint [1] 393870 0
From time of central venous catheter (CVC) insertion to CVC removal.
Secondary outcome [2] 393871 0
'Individual central venous catheter (CVC) failure' defined as pain, infiltration/extravasation, blockage/occlusion (with or without leakage), fracture, thrombosis, or dislodgement (complete or partial).
This outcome will be assessed through daily visualisation of the CVC, and notes from the patient's medical records.
Timepoint [2] 393871 0
From time of central venous catheter (CVC) insertion to CVC removal.
Secondary outcome [3] 393872 0
'Central line associated bloodstream infection' defined as a laboratory-confirmed bloodstream infection (BSI) where an eligible BSI organism is identified that is un-related to an infection at another site, the patient exhibits at least one of fever (>38.0°C), chills or hypotension (National Healthcare Safety Network (NHSN) common commensal organisms only), and an eligible central line is present on the day of or day before the event.
This outcome will be assessed by collating data from daily visual inspections and from patient medical records, which will then be assessed by an infectious disease specialist blinded to treatment allocation to confirm infectious outcome.
Timepoint [3] 393872 0
From CVC insertion to 48 hours after CVC removal.
Secondary outcome [4] 393873 0
'Primary BSI' defined as a laboratory-confirmed BSI where an eligible BSI organism is identified that is un-related to an infection at another site, the patient exhibits at least one of fever (>38.0°C), chills or hypotension (NHSN common commensal organisms only).
This outcome will be assessed by collating data from patient medical records, which will then be assessed by an infectious disease specialist blinded to treatment allocation to confirm infectious outcome.
Timepoint [4] 393873 0
From CVC infection to 48 hours after CVC removal.
Secondary outcome [5] 393874 0
‘Local infection’ as defined by the CDC/NHSN ‘Arterial or venous infection’ criteria: 1) Purulent drainage from vascular site, 2) Patient has at least one of fever, pain, erythema or heat at the vascular site with no other recognised source AND more than 15 CFU cultured from the catheter tip without corresponding bloodstream infection.
This outcome will be assessed by collating data from daily visual inspections of the CVC insertion site and from patient medical records, which will then be assessed by an infectious disease specialist blinded to treatment allocation to confirm infectious outcome.
Timepoint [5] 393874 0
From CVC infection to 48 hours after CVC removal.
Secondary outcome [6] 393875 0
'Loss of dressing integrity' defined as lifting at edges or lifting at edges requiring re-enforcement (all dressings per patient).
This outcome will be assessed through daily visualisation of the dressing, and notes from the patient's medical records.
Timepoint [6] 393875 0
From CVC insertion to CVC removal.
Secondary outcome [7] 393876 0
'Dressing dwell time' in days (all dressings per patient, from application to removal)
This outcome will be assessed through daily visualisation of the dressing, and notes from the patient's medical records.
Timepoint [7] 393876 0
From dressing application to dressing removal.
Secondary outcome [8] 393877 0
'Premature dressing removal' defined as before seven days from dressing application (all dressings per patient).
This outcome will be assessed through daily visualisation of the dressing, and notes from the patient's medical records.
Timepoint [8] 393877 0
From dressing application to dressing removal.
Secondary outcome [9] 393883 0
Number of dressing changes (from first application to last removal; all dressings per patient).
This outcome will be assessed through daily visualisation of the dressing, and notes from the patient's medical records.
Timepoint [9] 393883 0
From CVC insertion to CVC removal.
Secondary outcome [10] 393885 0
Device dwell-time (time from insertion to removal, in hours).
This outcome will be assessed through daily visualisation of the CVC, and notes from the patient's medical records.
Timepoint [10] 393885 0
From CVC insertion to CVC removal.
Secondary outcome [11] 393886 0
Serious adverse events (composite outcome of mortality, central line associated bloodstream infection and medical adhesive related skin injury),
Each SAE will be assessed and graded as per the Common Terminology for Adverse Events (version 5.0) by both the principal investigator at each recruiting site, and also the coordinating principal investigator.
Timepoint [11] 393886 0
From time of CVC insertion to 48 hours after CVC removal.
Secondary outcome [12] 396686 0
Adverse skin events relating to medical adhesive-related skin injury (MARSI) (e.g. pain, itch, erythema, skin stripping, blister, skin tear, irritant contact dermatitis, maceration, folliculitis or infection).
This outcome will be assessed through daily visualisation of the skin around the CVC insertion site underneath the dressing, and notes from the patient's medical records.
Timepoint [12] 396686 0
From time of CVC insertion to 48 hours after CVC removal.
Secondary outcome [13] 396688 0
Cost (cost and number of products used, cost of treating complications, staff time).
Number of products used will be totalled from CVC insertion to CVC removal as per information gained via visual inspections of the dressings and patient medical records.
Cost of products used will be based on standard hospital costs.
Costs of treating complications will be determined using a micro-costing approach with detailed resource use recorded in terms of procedures/treatments to rectify dressing-related complications.
Staff time will be calculated using local staffing wage rates (per hour), multiplied by time required to change dressings and number of dressing changes required.
Timepoint [13] 396688 0
From CVC insertion to CVC removal (plus the duration of any complications that arise from the CVC dwell).
Secondary outcome [14] 396689 0
Staff satisfaction on dressing application and removal (0 = not at all satisfied to 10 = completely satisfied).
Timepoint [14] 396689 0
At CVC insertion, dressing changes and CVC removal.
Secondary outcome [15] 396690 0
Skin colonisation, a composite measure of both organism and colony forming units.
This outcome will be assessed through qualitative/quantitative analysis of skin swabs of skin underneath the CVC dressing at the time of CVC removal by specialist pathology staff blinded to the intervention allocation.
Timepoint [15] 396690 0
Swabs will be taken in a subset of 10 patients per arm at the time of CVC removal.
Secondary outcome [16] 398251 0
Patient satisfaction of dressing application and removal (0 = not at all satisfied to 10 = completely satisfied).
Timepoint [16] 398251 0
At CVC insertion, dressing changes and CVC removal.

Eligibility
Key inclusion criteria
• 18 years or over
• Patient expected to require IJ CVC for greater or equal to 72 hours
• Requiring greater or equal to 24 hours treatment in the ICU
• Within 12 hours of CVC insertion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Emergency CVC insertion
• Bloodstream infection in 24 hours prior to CVC insertion (as defined by National Health and Safety Network)
• Pre-existing concurrent CVC expected to dwell for >24 hours
• Patient receiving end-of-life care
• Previous enrolment in this study

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2021
Actual
13/09/2021
Date of last participant enrolment
Anticipated
Actual
3/02/2023
Date of last data collection
Anticipated
Actual
13/02/2023
Sample size
Target
160
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 308299 0
Commercial sector/Industry
Name [1] 308299 0
Eloquest Healthcare
Country [1] 308299 0
United States of America
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia, Queensland, 4072
Country
Australia
Secondary sponsor category [1] 309717 0
None
Name [1] 309717 0
Address [1] 309717 0
Country [1] 309717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308275 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 308275 0
Royal Brisbane and Women's Hospital
Butterfield Street,
Herston, Queensland, 4029
Ethics committee country [1] 308275 0
Australia
Date submitted for ethics approval [1] 308275 0
Approval date [1] 308275 0
21/05/2021
Ethics approval number [1] 308275 0
HREC/2021/QRBW/73896
Ethics committee name [2] 308716 0
University of Queensland HREC
Ethics committee address [2] 308716 0
St Lucia, Queensland, 4072
Ethics committee country [2] 308716 0
Australia
Date submitted for ethics approval [2] 308716 0
Approval date [2] 308716 0
08/06/2021
Ethics approval number [2] 308716 0
2021/HE001361

Summary
Brief summary
Central venous catheters (CVCs) placed in the internal jugular vein have been associated with increased risk of central line-associated infection and CVC failure compared to subclavian CVCs. Effective dressing and securement of internal jugular CVCs can reduce the risk of such complications, but dressing and securement is often inadequate due to 'drag' of infusion lines on the CVC and intermittent 'catching' of the CVC lines on other objects. Dressing failure also increases the risk of medical adhesive-related skin injury and central line-associated bloodstream infection due to repeated dressing changes.

Mastisol Liquid Adhesive (MLA) is a non-water-soluble gum mastic liquid adhesive designed to improve dressing adherence and integrity. MLA has been shown to not increase bacterial growth and improve dressing adhesion in small studies, but has not been rigorously tested in a randomised controlled trial.

The aim of this study is to investigate the effectiveness of MLA in reducing dressing changes, adverse events (e.g. device failure, infection and MARSI), clinician workload and costs associated with IJ CVCs.

It is hypothesised that dressings secured with MLA will required changes less frequently, and therefore be associated with less adverse events, lower clinician workload and costs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110154 0
Dr Nicole Marsh
Address 110154 0
Level 2, Building 34 (Centre for Clinical Nursing)
Royal Brisbane and Women's Hospital
Butterfield Street,
Herston, Queensland, Australia, 4029
Country 110154 0
Australia
Phone 110154 0
+61 7 3646 8590
Fax 110154 0
Email 110154 0
nicole.marsh@health.qld.gov.au
Contact person for public queries
Name 110155 0
Ms Catherine O'Brien
Address 110155 0
Level 2, Centre for Clinical Nursing, Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Queensland, 4029
Country 110155 0
Australia
Phone 110155 0
+61 7 3646 8725
Fax 110155 0
Email 110155 0
catherine.obrien2@health.qld.gov.au
Contact person for scientific queries
Name 110156 0
Dr Nicole Marsh
Address 110156 0
Level 2, Building 34 (Centre for Clinical Nursing)
Royal Brisbane and Women's Hospital
Butterfield Street,
Herston, Queensland, Australia, 4029
Country 110156 0
Australia
Phone 110156 0
+61 7 3646 8590
Fax 110156 0
Email 110156 0
nicole.marsh@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified patient data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Only researchers who provide a methodologically sound proposal and at the discretion of the Principal Investigator
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Data can be obtained from the Principal Investigator (Dr Nicole Marsh, nicole.marsh@health.qld.gov.au)


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.