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Trial registered on ANZCTR


Registration number
ACTRN12625000137493
Ethics application status
Approved
Date submitted
15/01/2025
Date registered
6/02/2025
Date last updated
6/02/2025
Date data sharing statement initially provided
6/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Supplemental Tackifier to Intravenous Catheter dressings to Keep intact Year-round in Kids (the STICKY Kids trial).
Scientific title
Supplemental Tackifier to Intravenous Catheter dressings to Keep intact Year-round in Kids (the STICKY Kids trial).
Secondary ID [1] 312493 0
nil
Universal Trial Number (UTN)
Trial acronym
STICKY Kids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous access device dressing complications
 334350 0
Central venous access device related adverse events 334351 0
Condition category
Condition code
Public Health 332013 332013 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mastisol Liquid Adhesive (0.6ml individual vial blister pack) will be applied in conjunction with standard care dressing for central venous access devices (CVAD). This will occur each time the dressing is required to be changed based on clinical requirement due to altered dressing integrity, and at least once weekly as per organisational policy. This will continue at each dressing change for up to 8 weeks or until the CVAD is removed (whichever occurs first).
All dressing changes including application of the Mastisol Liquid Adhesive will be clinically managed by the Hospital in the Home (HITH) nursing team and will take place in the home care environment.
Data will be collected by the HITH nursing team on a paper-based data collection tool which will be returned to the research team daily. Additional data will be collected from the electronic medical record, and directly from the patient/ family where required.
Intervention code [1] 329742 0
Prevention
Comparator / control treatment
Children not randomised to the intervention arm will continue to receive standard care dressing for central venous access devices. Standard care dressing is defined as a bordered transparent polyurethane dressing, with the use of additional device securement devices as clinically indicated (including subcutaneously anchored securement systems and sutureless securement devices)
Control group
Active

Outcomes
Primary outcome [1] 339616 0
Dressing Disruption during routine dressing schedule. Defined as the requirement for any CVAD dressing to be replaced prematurely and/or re-enforced due to disruption in dressing integrity at (e.g., lifted/detached on any border edge or within the transparent portion of dressing; visibly soiled; presence of moisture, drainage, or blood) prior to scheduled dressing change (before planned/routine change at seven days or catheter removal)
Timepoint [1] 339616 0
Daily from time of application of allocated dressing, for up to 8 weeks or until the CVAD is removed (whichever occurs first).
Secondary outcome [1] 440598 0
Dressing Disruption Counts (defined as requirement for any intravenous catheter dressing to be replaced prematurely and/or re-enforced due to disruption in dressing integrity (e.g., Dressing disruption counts. Defined as requirement for any intravenous catheter dressing to be replaced prematurely and/or reinforced due to disruption in dressing integrity (e.g. lifted/detached on any border edge or within transparent portion of dressing; visibly soiled; presence of moisture, drainage, or blood) during study period
Timepoint [1] 440598 0
Daily until device removal or up to 8 weeks
Secondary outcome [2] 440599 0
Dressing dwell time in days (from application to intervention [requiring dressing change or re-enforcement] for each dressing change period) within the routine dressing schedule (7 days; up to week 8)
Timepoint [2] 440599 0
Daily from dressing application to intervention [requiring dressing change or re-enforcement] for each dressing change period - up to 8 weeks or until CVAD removal (whichever occurs first).
Secondary outcome [3] 440600 0
Primary bloodstream infection
Timepoint [3] 440600 0
Daily until device removal or up to 8 weeks (whichever occurs first)
Secondary outcome [4] 440601 0
All cause CVAD failure (premature device removal due to pain, thrombosis, occlusion, infection and dislodgement)-during study period
Timepoint [4] 440601 0
Daily until device removal or up to 8 weeks (whichever occurs first)
Secondary outcome [5] 440602 0
Skin adverse event profiles (e.g., rash, blister, itchiness, skin tears, MARSI) during the study period
Timepoint [5] 440602 0
Daily until device removal or up to 8 weeks (whichever occurs first)
Secondary outcome [6] 440603 0
Cost (composite of cost and number of products used, cost of treating complications, staff time).
Number of products used will be totalled from application of allocated dressing 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 [6] 440603 0
At each dressing change until device removal or up to 8 weeks (whichever occurs first)
Secondary outcome [7] 440604 0
Overall patient/parent satisfaction at dressing change (0 = not at all satisfied to 10 = completely satisfied).
Timepoint [7] 440604 0
At each dressing change from application of allocated dressing until device removal or 8 weeks (whichever occurs first)
Secondary outcome [8] 440605 0
Overall clinician satisfaction with dressing regime at dressing application and removal (0 = not at all satisfied to 10 = completely satisfied
Timepoint [8] 440605 0
At each dressing change from application of allocated dressing until device removal or 8 weeks (whichever occurs first)
Secondary outcome [9] 444388 0
Local infection
Timepoint [9] 444388 0
Daily until device removal or up to 8 weeks (whichever occurs first)
Secondary outcome [10] 444389 0
Infiltration and extravasation (composite)
Timepoint [10] 444389 0
Daily until device removal or up to 8 weeks (whichever occurs first)
Secondary outcome [11] 444390 0
Blockage/ occlusion (partial/complete, with or without leakage)
Timepoint [11] 444390 0
Daily until device removal or up to 8 weeks (whichever occurs first)
Secondary outcome [12] 444391 0
Dislodgement (complete or partial)
Timepoint [12] 444391 0
Daily until device removal or up to 8 weeks (whichever occurs first)

Eligibility
Key inclusion criteria
less than or equal to 18 years at recruitment
Patient expected to require central venous access device > 7 days
Requiring intravenous treatment in Hospital in the Home (HITH)
Informed consent to participate.
Vessel size appropriate for >3fr catheter or larger
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under the care of child services (if unable to obtain consent)
Patient receiving end-of-life care.
Allergy to study product
Significantly impaired skin surrounding insertion site of vascular access device (e.g., eczema, burn, open wound)
<3fr device

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)
Web based central randomisation service (REDCap)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised to the MLA (and standard care) or standard care groups in a 1:1 ratio, with randomly varied block sizes of 4 and 6. Patients will be stratified by age (0 - 2 years, >2 – 12 years, >12 – 18 years), and timing of intervention (initial dressing or subsequent dressing)
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
Summaries of continuous variables that are normally distributed will be presented as means and standard deviations or as medians and inter-quartile ranges for skewed data. Categorical variables will be presented as frequencies and percentages.

All randomised patients will be analysed by intention-to-treat as primary analysis. A per-protocol analysis will assess the effect of protocol violations. The primary outcome, dressing disruption, will be analysed using mixed effects logistic regression with ‘treatment’ as the main effect and child as a random effect to account for repeated observations. Kaplan-Meier survival curves (with log-rank Mantel-Cox test) will compare dressing disruption over time. All tests will be two-sided, with a significance level set at 0.05.

Other secondary clinical outcomes will be compared between groups with appropriate parametric or non-parametric techniques. For outcomes collected weekly, mixed effects models will be used. For outcomes collected over the entire study period, logistic regression (for binary outcomes) or Poisson regression (for count data) will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26772 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 42823 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 316913 0
Commercial sector/Industry
Name [1] 316913 0
Eloquest Healthcare, Inc
Country [1] 316913 0
United States of America
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 320503 0
None
Name [1] 320503 0
Address [1] 320503 0
Country [1] 320503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315671 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 315671 0
http://www.childrens.health.qld.gov.au/research/human-research-ethics-committee
Ethics committee country [1] 315671 0
Australia
Date submitted for ethics approval [1] 315671 0
02/12/2024
Approval date [1] 315671 0
16/01/2025
Ethics approval number [1] 315671 0

Summary
Brief summary
The objective of this study is to determine if the use of Mastisol Liquid Adhesive in conjunction with standard care reduces dressing disruption prior to scheduled weekly dressing change and is associated with fewer CVAD complications in children receiving in-home care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135450 0
Ms Tricia Kleidon
Address 135450 0
Queensland Children's Hospital, 501 Stanley Street South, Brisbane, QLD 4101
Country 135450 0
Australia
Phone 135450 0
+61 07 3068 5160
Fax 135450 0
Email 135450 0
[email protected]
Contact person for public queries
Name 135451 0
Tricia Kleidon
Address 135451 0
Queensland Children's Hospital, 501 Stanley Street South, Brisbane, QLD 4101
Country 135451 0
Australia
Phone 135451 0
+61 07 3068 5160
Fax 135451 0
Email 135451 0
[email protected]
Contact person for scientific queries
Name 135452 0
Tricia Kleidon
Address 135452 0
Queensland Children's Hospital, 501 Stanley Street South, Brisbane, QLD 4101
Country 135452 0
Australia
Phone 135452 0
+61 07 3068 5160
Fax 135452 0
Email 135452 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.