Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000536460
Ethics application status
Approved
Date submitted
2/05/2025
Date registered
27/05/2025
Date last updated
27/05/2025
Date data sharing statement initially provided
27/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Subcutaneously anchored securement system versus a traditional sutureless securement device for the prevention of Peripherally Inserted Central Catheter dislodgement: A randomised controlled trial
Scientific title
Subcutaneously anchored securement system versus a traditional sutureless securement device for the prevention of Peripherally Inserted Central Catheter dislodgement: A randomised controlled trial
Secondary ID [1] 314188 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SASS vs STAND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catheter Dislodgement 337120 0
Condition category
Condition code
Cardiovascular 333540 333540 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised between statlock (Standard of care) or to the SecurAcath (intervention) arm.
The SecurAcath device is a small, subcutaneous anchor securement system that is inserted in the subcutaneous layer, and held in place by small metal feet that act as anchors. The device will be inserted by trained radiology nurse and/or trained medical officer. The device will stay in place for the lifeline of the Peripherally Inserted Central Catheter (PICC) line in the patient - this could be 1 week or up to 1 year (or more in very rare cases). The SecurAcath device will only be applied the one time. If it is removed or dislodged for any reason, there is no cross-enrolment to the control arm. Strategies used to assess adherence to both arms include monthly follow up with the patient - either in person at appointments or via a phone call.
Intervention code [1] 330827 0
Prevention
Intervention code [2] 331090 0
Treatment: Devices
Comparator / control treatment
Control arm is the use of the statlock, which secures the PICC line via a sticker on the skin, holding the catheter in place. The statlock will be applied at completion of device insertion by the inserting clinician (trained registered nurse or medical officer).
It will be affixed to the patients’ skin using a large adhesive padded footplate with plastic locking clasps, and a transparent dressing placed over the point of insertion. The statlock is changed weekly and then at device removal. It is peeled away gently from the skin and the plastic locking clips must be opened to allow for the removal of the catheter from the device.
Control group
Active

Outcomes
Primary outcome [1] 341303 0
Dislodgement (binary): greater than 1cm movement in the catheter tip position at any point during PICC dwell; including both partial and total dislodgement.
Timepoint [1] 341303 0
72 hours post insertion, and then monthly until PICC line removal and/or at PICC line removal
Secondary outcome [1] 447071 0
Central Venous Access Device (CVAD)-Associated skin impairment
Timepoint [1] 447071 0
In addition to throughout: 72 hours post insertion; monthly and then at PICC and/or device removal
Secondary outcome [2] 447073 0
Catheter adverse events
Timepoint [2] 447073 0
In addition to throughout: 72 hours post insertion; monthly and at PICC and/or device removal
Secondary outcome [3] 447074 0
Dwell time of study device
Timepoint [3] 447074 0
On device removal
Secondary outcome [4] 447075 0
Healthcare costs
Timepoint [4] 447075 0
At end of last patient completing follow up
Secondary outcome [5] 448058 0
catheter associated-thrombosis
Timepoint [5] 448058 0
In addition to throughout: 72 hours post insertion; monthly and at PICC and/or device removal
Secondary outcome [6] 448059 0
extravasation
Timepoint [6] 448059 0
In addition to throughout: 72 hours post insertion, monthly and at PICC and/or device removal
Secondary outcome [7] 448060 0
Occlusion (complete)
Timepoint [7] 448060 0
In addition to throughout catheter use: 72 hours post insertion, monthly and at PICC and/or device removal.
Secondary outcome [8] 448061 0
Central Line-Associated Bloodstream Infection (CLABSI)
Timepoint [8] 448061 0
Routine management - at any point that CLABSI is suspected. In addition, to 72 hours post insertion and monthly.
Secondary outcome [9] 448062 0
local infection
Timepoint [9] 448062 0
routine use of catheter, 72 hour post insertion follow up, monthly and at device removal.

Eligibility
Key inclusion criteria
1. 16 years of age or older and
requiring PICC insertion in Medical Imaging, Toowoomba Hospital.
2. Informed consent given by patient or substitute decision maker
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-English speakers without an interpreter
2. Unable to consent, or without a legal guardian.
3. Patient receiving end-of-life care
4. Previous enrolment in this study
5. Patients with an indeterminate length of treatment (likely less than 2 weeks)
6. Known allergy to any of the study products (in particular nickel allergy).

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) 1:1
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Characteristics of groups at baseline will be assessed using demographic, social and clinical parameters. Means and standard deviations will be used to report normally distributed continuous data, medians and interquartile ranges will be used for interval data that could not be approximated with a normal distribution. Categorical data will be reported as frequency (percentage). Incidence rates (per 1,000 PICC days) including 95% confidence intervals will be calculated.
Primary and secondary binary outcomes will be compared between groups using logistic regression. Count outcomes will be compared using Poisson regression models, with the natural logarithm of time-at-risk included. Continuous outcomes will be compared using linear regression models. The patient is the unit of analysis. Detailed estimands will be developed to explore the effect of intercurrent events such as protocol deviations. Multivariable regression will be undertaken as a secondary analysis to explore the effect of baseline characteristics associated with the primary outcome. Missing values are expected to be minimal, random and will not be imputed, but will be reported. P values of p<0.05 will be considered statistically significant. The statistican will be masked to group allocation and a comprehensive statistical analysis plan will be developed and finalised prior to statistical analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2025
Actual
Date of last participant enrolment
Anticipated
3/06/2027
Actual
Date of last data collection
Anticipated
3/06/2029
Actual
Sample size
Target
384
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27867 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 44062 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 318706 0
Government body
Name [1] 318706 0
Darling Downs Health
Country [1] 318706 0
Australia
Primary sponsor type
Government body
Name
Darling Downs Health
Address
Country
Australia
Secondary sponsor category [1] 321135 0
None
Name [1] 321135 0
Address [1] 321135 0
Country [1] 321135 0
Other collaborator category [1] 283507 0
University
Name [1] 283507 0
University of Queensland
Address [1] 283507 0
Country [1] 283507 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317312 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 317312 0
Ethics committee country [1] 317312 0
Australia
Date submitted for ethics approval [1] 317312 0
26/11/2024
Approval date [1] 317312 0
08/01/2025
Ethics approval number [1] 317312 0
113629

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

Contacts
Principal investigator
Name 140662 0
Dr Sally Havers
Address 140662 0
UQ Centre for Clinical Research, Herston, QLD, 4006
Country 140662 0
Australia
Phone 140662 0
+61 0433 570 585
Fax 140662 0
Email 140662 0
[email protected]
Contact person for public queries
Name 140663 0
Sally Havers
Address 140663 0
UQ Centre for Clinical Research, Herston, QLD, 4006
Country 140663 0
Australia
Phone 140663 0
+61 0433 570 585
Fax 140663 0
Email 140663 0
[email protected]
Contact person for scientific queries
Name 140664 0
Sally Havers
Address 140664 0
UQ Centre for Clinical Research, Herston, QLD, 4006
Country 140664 0
Australia
Phone 140664 0
+61 0433 570 585
Fax 140664 0
Email 140664 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.