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Trial registered on ANZCTR


Registration number
ACTRN12614001329651
Ethics application status
Approved
Date submitted
8/12/2014
Date registered
17/12/2014
Date last updated
7/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The securement and dressing of percutaneous central venous access devices (CVADs) in the paediatric intensive care: a pilot randomised controlled trial
Scientific title
Randomised controlled trial of tissue adhesive, combined securement and dressing product or external stabilisation devices versus standard care (bordered polyurethane) dressings to prevent central venous access device failure in paediatric intensive care patients with percutaneous central venous access devices: the CASCADE Junior PICU trial
Secondary ID [1] 285803 0
Nil
Universal Trial Number (UTN)
U1111-1165-0095
Trial acronym
CASCADE Junior PICU Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous access device failure and complication prior to completion of therapy 293698 0
Condition category
Condition code
Public Health 293998 293998 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in this study have central venous access devices (CVADs) used in paediatric intensive care departments. Consenting parents or legal guardians, and patients (if appropriate) will have their percutanaeous CVADs secured
with one of the following randomly assigned dressings and securements:
Arm 1: Tissue Adhesive (TA) is a medical grade 'superglue'
(cyanoacrylate) used mainly to close skin lacerations/wounds as an alternative to sutures and staples. A bordered polyurethane dressing will also be applied.
Arm 2: Sutureless Stabilisation Device (SSD) have a large adhesive padded footplate with locking clasp made of hard plastic. SSD are used in addition to bordered polyurethane.
Arm 3: Combined securement and dressing product: extra-reinforced borders, with an absorbent layer around the polyurethane claimed to ‘wick’ moisture away from the wound
Arm 4 (Control): Bordered polyurethane (BPU) dressings involve a clear polyurethane with an added external adhesive border of foam or cloth fabric. They will also have their CVAD secured with prolene sutures.
The randomly allocated dressing will be applied until completion of therapy, hospital discharge or at 4 weeks. The dressing will be applied at CVAD insertion and then changed every 7 days, or on disruption of the dressing integrity.
Intervention code [1] 290777 0
Prevention
Intervention code [2] 290828 0
Treatment: Devices
Comparator / control treatment
Arm 4 (Control): Bordered polyurethane (BPU) dressings involve a clear polyurethane with an added external adhesive border of foam or cloth fabric. They will also have their CVAD secured with prolene sutures.
Control group
Active

Outcomes
Primary outcome [1] 293780 0
CVAD failure:
Composite measure of any reason for unplanned CVAD removal or complication, prior to the completion of therapy. This includes (i) Central Line-Associated Bloodstream Infection (CLABSI); (ii) local infection of skin or sutures: (iii) dislodgement: (iv) occlusion and (v) CVAD breakage.
The primary outcome of device failure is an objective measure, assigned by clinical staff (not research staff or investigators). This is routine clinical practice. Research staff will collect the primary endpoint from the medical records with additional information obtained from the clinical staff/patients if required
Timepoint [1] 293780 0
At time of CVAD removal, hospital discharge or 4 weeks.
Primary outcome [2] 293781 0
Feasibility of a full efficacy trial as established by:
*Eligibility: Percentage of patients screened that are eligible;
*Recruitment: Percentage of eligible patients who agree to enrol;
*Retention and attrition: Percentage of participants who are lost to followup or withdraw from study;
*Protocol adherence: Percentage of participants who receive their
allocated treatment throughout their study participation;
*Missing data: Percentage of data missed during study data collection;
*Parent and healthcare staff satisfaction and acceptability: Using a semistructured survey; and
*Sample size estimates: a reduction in all-case CVAD failure (defined in the secondary outcomes) by at least 5% in the experimental arms, in comparison to standard care.
Timepoint [2] 293781 0
At conclusion of study
Secondary outcome [1] 311813 0
Central line-associated bloodstream infection (CLABSI):
A laboratory-confirmed bloodstream infection (LCBI) in a patient who had a central line within the 48 hour period before the development of the BSI, and that is not related to an infection at another site. The CLABSI must meet one of the following criteria of LCBI:
Criterion 1: Patient has a recognised pathogen cultured from one or more blood cultures and Organism cultured from blood is not related to an infection at another site. OR
Criterion 2: Patient has at least one of the following signs or
symptoms: fever (greater than 38 degrees C), chills, or hypotension, and signs and symptoms and positive laboratory results are not related to an infection at another site, and common skin contaminant* is cultured from two or more blood cultures drawn on separate occasions. Examples of common skin contaminants: diphtheroids [Corynebacterium spp.], Bacillus [not B. anthracis] spp., Propionibacterium spp., coagulasenegative staphylococci [including S. epidermidis], viridans group streptococci, Aerococcus spp., Micrococcus spp.
Timepoint [1] 311813 0
At CVAD removal, hospital discharge or 4 weeks.
Secondary outcome [2] 311814 0
Local infection of the skin:
Purulent discharge, or redness extending 1cm beyond the site that
prompts clinician to order removal or commence antimicrobial therapy.
Timepoint [2] 311814 0
At CVAD removal, hospital discharge or 4 weeks.
Secondary outcome [3] 311815 0
Dislodgement:
Partial: any post-insertion change in the length of the CVAD body from the hub to the CVAD tip, as measured by the catheter marking in closest approximation to hub.
Total: CVAD body completely leaves the vein, or must be removed
because CVAD tip is no longer in the superior vena cava (diagnosed by XRay/leakage from site on injection/clinician diagnosis)
Timepoint [3] 311815 0
At CVAD removal, hospital discharge or 4 weeks.
Secondary outcome [4] 311816 0
Occlusion:
>/=1 lumen unable to be flushed/aspirated, diagnosed by treating
clinician
Timepoint [4] 311816 0
At CVAD removal, hospital discharge or 4 weeks.
Secondary outcome [5] 311817 0
CVAD breakage:
Visible split in CVAD material diagnosed by treating clinician
Timepoint [5] 311817 0
At CVAD removal, hospital discharge or 4 weeks.
Secondary outcome [6] 311818 0
Dressing/securement failure:
Early replacement before seven days for loose, soiled or missing
dressings
Timepoint [6] 311818 0
At seven days after dressing application
Secondary outcome [7] 311819 0
Parent and staff satisfaction and acceptability ranked on a 10-point
scale
Timepoint [7] 311819 0
At device removal, within 24 hours of removal, at hospital discharge or 4 weeks.
Secondary outcome [8] 311820 0
CVAD dwell time, and dressing dwell time:
Time in hours from insertion/application until removal
Timepoint [8] 311820 0
At the time of CVAD removal.

Eligibility
Key inclusion criteria
Inclusion criteria:
*Patient requires the insertion of a percutaneous CVAD for >24 hours;
*Will remain in admitted to the RCH/LCCH for >24 hours;
* Less than 16 years of age; and
*Parent or legal guardian, and child if developmentally appropriate, gives informed consent.
Minimum age
No limit
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
*Tunnelled, peripherally inserted, dialysis, or implanted CVADs or pulmonary artery catheters;
*Current bloodstream infection;
*CVAD to be inserted through diseased, burned or scarred skin;
*Allergy to study product; and
*Previous study enrolment in this admission to hospital

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)
The research nurse (RN) will screen patients daily (screening log kept), gain informed consent, and perform randomisation. The RN will have the study products in pre-packs and liaise closely with the ordering and inserting physician. All elligible patients (or their representative) will be approached for written informed consent by the RN or inserter. If this is given, the staff member use a centralised web-based randomisation service. Allocation is fully concealed until the patient is randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated. Randomisation will be in a 1:1:1:1 ratio between the four study groups. Permuted blocks in randomly varied sizes will be used.
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
All randomised patients will be analysed by intention to treat, regardless of treatment received. The patient is the unit of measurement with one CVAD per patient.
Feasibility outcomes will be described using descriptive statistics
including mean, median, range, IQR, counts and percentages.
Comparability of groups at baseline will be assessed using clinical parameters. Relative incidence rates of CVAD and dressing failure per 100 devices and per 1,000 device days with 95% confidence intervals (CIs) will summarise the impact of each dressing, and to test difference between groups. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare CVAD failure over time. Secondary endpoints including CVAD dwell-time, costs, dislodgement, occlusion, CVAD breakage, patient/staff satisfaction scores and adverse events will be compared between groups using parametric/nonparametric techniques as appropriate. Data will be exported into PASW 21.0 (SPSS Inc, Chicago, IL). Prior to analysis, data cleaning of outlying figures, missing, and implausible data will be undertaken, and a random 5% sample of source data rechecked. All attempts will be made to collect the primary endpoint. Missing data will be modelled for best- and worst-case outcomes to assess for effect on overall results. A per-protocol analysis will assess the effect of protocol
violations. P values of <0.05 will be considered significant.
Sample size and study power: This is a pilot study to gain information to prepare for an efficacy trial. Twenty participants per study arm will be recruited - totaling 80 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3239 0
Royal Children's Hospital - Herston
Recruitment hospital [2] 3265 0
Lady Cilento Children's Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 290367 0
University
Name [1] 290367 0
Griffith University
Address [1] 290367 0
Nathan Campus,
170 Kessels Road
Nathan, QLD 4111
Country [1] 290367 0
Australia
Funding source category [2] 290368 0
Commercial sector/Industry
Name [2] 290368 0
Centurion Medical Products
Address [2] 290368 0
100 Centurion Way
Williamston, MI 48895
Unites States of America
Country [2] 290368 0
United States of America
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus,
170 Kessels Road
Nathan, QLD 4111
Country
Australia
Secondary sponsor category [1] 289089 0
None
Name [1] 289089 0
Address [1] 289089 0
Country [1] 289089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292070 0
Children's Health Services, Queensland
Ethics committee address [1] 292070 0
Royal Children's Hospital,
Herston Rd
Herston, QLD 4029
Ethics committee country [1] 292070 0
Australia
Date submitted for ethics approval [1] 292070 0
Approval date [1] 292070 0
14/11/2013
Ethics approval number [1] 292070 0
HREC/13/QRCH/181
Ethics committee name [2] 292071 0
Griffith University
Ethics committee address [2] 292071 0
Nathan Campus,
170 Kessels Road
Nathan, QLD 4111
Ethics committee country [2] 292071 0
Australia
Date submitted for ethics approval [2] 292071 0
Approval date [2] 292071 0
20/02/2014
Ethics approval number [2] 292071 0
NRS/10/14/HREC

Summary
Brief summary
Children admitted to a paediatric intensive care unit (PICU) frequently require the insertion of a CVAD for the administration of medication and fluids. These CVADs are associated with a high rate of failure, including CVAD-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU), are used to protect the CVAD insertion site from contamination. Additional securement devices, such as sutures, are used to reduce movement of the catheter.
New products, including tissue adhesive (TA), sutureless securement devices (SSD), and combined securement and dressing products (CSD), are available to clinicians to provide securement and dressings for CVAD. It is not known whether these new products are effective at reducing CVAD
failure, in comparison to standard care (BPU and suture).
The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of dressings and securement products on CVAD failure due to infection, occlusion, dislodgement, thrombosis, or breakage, for children
with percuteanous CVAD in the PICU.
Trial website
Trial related presentations / publications
Nil to date
Public notes

Contacts
Principal investigator
Name 53338 0
Dr Debbie Long
Address 53338 0
Paediatric Intensive Care Unit
Royal Children's Hospital
Herston Rd
HERSTON QUEENSLAND 4029
Country 53338 0
Australia
Phone 53338 0
+61 7 3646 9204
Fax 53338 0
Email 53338 0
debbie.long2@health.qld.gov.au
Contact person for public queries
Name 53339 0
Ms Amanda Ullman
Address 53339 0
NHMRC Centre of Research Excellence in Nursing
Griffith University
Nathan Campus
170 Kessels Road, Nathan, QUEENSLAND 4111
Country 53339 0
Australia
Phone 53339 0
+61 7 3735 7854
Fax 53339 0
Email 53339 0
a.ullman@griffith.edu.au
Contact person for scientific queries
Name 53340 0
Ms Amanda Ullman
Address 53340 0
NHMRC Centre of Research Excellence in Nursing
Griffith University
Nathan Campus
170 Kessels Road, Nathan, QUEENSLAND 4111
Country 53340 0
Australia
Phone 53340 0
+61 7 3735 7854
Fax 53340 0
Email 53340 0
a.ullman@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary