Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001657112p
Ethics application status
Submitted, not yet approved
Date submitted
31/10/2019
Date registered
27/11/2019
Date last updated
27/11/2019
Date data sharing statement initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the PICCsox arm cover on the risk of the peripherally inserted central catheter (PICC) coming out and the experience of the patient
Scientific title
Dislodgements and patient experience of the PICCsox in patients receiving a peripherally inserted central catheter (PICC)
Secondary ID [1] 299316 0
None
Universal Trial Number (UTN)
Trial acronym
PICCsox
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PICC dislodgement 315009 0
Condition category
Condition code
Cancer 313348 313348 0 0
Any cancer
Infection 313349 313349 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients allocated to the intervention group will have the standard dressing and securement device. In addition, they will be provided with a PICCsox. The appropriate size will be selected by the PICC nurse.
The PICCsox is a bamboo arm cover that is worn over the usual PICC dressing. The PICCsox will be initially applied by the PICC nurse. The PICCsox will be worn daily for 6 weeks post PICC insertion. However, it is easily removed, and the participants will decide how often and when they wear the PICCsox. Participants will be asked about the pattern of wear during the telephone interviews.
Intervention code [1] 315934 0
Treatment: Devices
Comparator / control treatment
Patients allocated to the control group will receive usual care (standard dressing and securement device without an arm cover). They will not receive a PICCsox. However, they will be offered a PICCsox at the end of six weeks on the trial.
Control group
Active

Outcomes
Primary outcome [1] 321825 0
The primary outcome will be PICC dislodgement rate as per patient report
Timepoint [1] 321825 0
6 weeks post PICC insertion
Secondary outcome [1] 377146 0
The secondary outcome is the patient experience of the PICCsox (comfort and satisfaction with the PICCsox and impact on daily living) as per patient interview
Timepoint [1] 377146 0
6 weeks post PICC insertion

Eligibility
Key inclusion criteria
All adult (18 years or older) patients booked for PICC insertion above the ante-cubital fossa region (usual practice) by the PICC nurse inserter in the Radiology Department of the Royal Adelaide Hospital who are willing to be contacted by telephone at six weeks post insertion.
Patients who have haematological cancers, solid tumours, infection and those with difficult venous access who require a PICC and fit this criteria will be approached.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
PICC not inserted in arm
Patient unable to provide informed consent
Patient in palliation

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)
Randomisation will be performed by a statistician not involved in clinical care. The nurse-led PICC insertion team will be provided with 140 sealed envelopes each containing a patient allocation to one of the two groups. The envelopes will be sequentially numbered. As each new patient is recruited, the envelope for their study number will be opened to show the allocation.
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)
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
Assuming at six weeks a PICC dislodgment rate of 30% in the Control group, and 10% in the Intervention group, then a sample of 59 patients in each group would be required to show this difference to be statistically significant, with 80% power and a required alpha of 0.05, and using a chi-squared test. To allow for any patients lost to follow up, 70 patients will be recruited in each study arm.

Descriptive statistics will then be presented using counts and percentages for categorical variables and means and standard deviations for continuous variables. The primary outcome measure will be compared between groups using a chi-squared test. If any imbalance is seen between baseline variables, then adjusted models will be undertaken using log binomial generalized linear models.
All reporting will be by intention to treat. There will be no attempt to undertake imputation of missing values.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/12/2019
Actual
Date of last participant enrolment
Anticipated
10/02/2020
Actual
Date of last data collection
Anticipated
13/04/2020
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15064 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 28355 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 303835 0
Commercial sector/Industry
Name [1] 303835 0
FloMedical
Country [1] 303835 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471 Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 304376 0
Hospital
Name [1] 304376 0
Royal Adelaide Hospital
Address [1] 304376 0
1 Port Road, Adelaide, SA 5000
Country [1] 304376 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304350 0
Central Adelaide Local Health Network
Ethics committee address [1] 304350 0
Ethics committee country [1] 304350 0
Australia
Date submitted for ethics approval [1] 304350 0
22/11/2019
Approval date [1] 304350 0
Ethics approval number [1] 304350 0

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

Contacts
Principal investigator
Name 96642 0
Dr Rebecca Sharp
Address 96642 0
University of South Australia
GPO Box 2471 Adelaide SA 5001
Country 96642 0
Australia
Phone 96642 0
+61 08 83022027
Fax 96642 0
Email 96642 0
[email protected]
Contact person for public queries
Name 96643 0
Rebecca Sharp
Address 96643 0
University of South Australia
GPO Box 2471 Adelaide SA 5001
Country 96643 0
Australia
Phone 96643 0
+61 08 83022027
Fax 96643 0
Email 96643 0
[email protected]
Contact person for scientific queries
Name 96644 0
Adrian Esterman
Address 96644 0
University of South Australia
GPO Box 2471 Adelaide SA 5001
Country 96644 0
Australia
Phone 96644 0
+61 08 830 22163
Fax 96644 0
Email 96644 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
As per HREC requirements


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.