Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001103752
Ethics application status
Approved
Date submitted
25/09/2013
Date registered
2/10/2013
Date last updated
4/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Central venous Access device SeCurement And Dressing Effectiveness: the CASCADE Trial
Scientific title
Randomised controlled trial of tissue adhesive, absorbent dressings or external stabilisation devices versus standard care (bordered polyurethane) dressings to prevent central venous access device failure in hospital patients with central venous access devices: the CASCADE trial
Secondary ID [1] 283307 0
Nil
Universal Trial Number (UTN)
U1111-1148-4723
Trial acronym
The CASCADE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous access device failure prior to completion of therapy 290190 0
Condition category
Condition code
Public Health 290578 290578 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 medical, surgical, anaesthetic and intensive care departments, and include adult and paediatric patients. Consenting patients will have their 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.

Arm 2: Sutureless Stabilisation Device (SSD) have a large adhesive padded footplate with locking clasp made of hard plastic or self-gripping soft fasteners. SSD are used in addition to standard polyurethane.

Arm 3: Absorbent dressings which combine the durability and visibility of the transparent polyurethane, whilst including an absorbent pad.

Arm 4 (Control): Bordered polyurethane (BPU) dressings involve a clear polyurethane with an added external adhesive border of foam or cloth fabric.

The randomly allocated dressing will be applied until completion of therapy. The dressing will be applied at CVAD insertion and then changed every 7 days, or on disruption of the dressing integrity.
Intervention code [1] 288027 0
Prevention
Intervention code [2] 288061 0
Treatment: Devices
Comparator / control treatment
Control group patients will have their central venous access devices secured with bordered polyurethane (BPU) dressings (as per usual care) until completion of therapy.
Control group
Active

Outcomes
Primary outcome [1] 290597 0
CVAD failure:

Composite measure of any reason for unplanned CVAD removal, 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] 290597 0
At the time of CVAD removal.
Secondary outcome [1] 304865 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., coagulase-negative staphylococci [including S. epidermidis], viridans group streptococci, Aerococcus spp., Micrococcus spp.
Timepoint [1] 304865 0
At time of CVAD removal.
Secondary outcome [2] 304866 0
Local infection of the skin:

Purulent discharge, or redness extending 1cm beyond the site that prompts clinician to order removal and commence antimicrobial therapy.
Timepoint [2] 304866 0
At time of CVAD removal
Secondary outcome [3] 304867 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] 304867 0
At time of CVAD removal
Secondary outcome [4] 304868 0
Occlusion:

>/=1 lumen unable to be flushed/aspirated, diagnosed by treating clinician
Timepoint [4] 304868 0
At time of CVAD removal.
Secondary outcome [5] 304869 0
CVAD breakage:

Visible split in CVAD material diagnosed by treating clinician

Timepoint [5] 304869 0
At time of CVAD removal.
Secondary outcome [6] 304870 0
Dressing/securement failure:

Early replacement before seven days for loose, soiled or missing dressings
Timepoint [6] 304870 0
At seven days after dressing application.
Secondary outcome [7] 304871 0
CVAD dwell time, and dressing dwell time:

Time in hours from insertion/application until removal
Timepoint [7] 304871 0
At the time of CVAD removal.
Secondary outcome [8] 304872 0
Device colonisation or skin site colonisation (>15cfu):

CVAD and skin cultures will be performed by the RNs on CVAD removal. Moistened sterile swabs will be used to swab skin at the insertion site and then placed in transport media.

CVAD specimens (distal segments) will be placed in sterile tubes, transferred to the laboratory and roll-plated for semi-quantitative culture.

After 24 h incubation, plates will be examined for bacterial colony counts. The plates will then be re-incubated for 72 hrs to enable growth of slow-growing species. Species identification will be determined morphologically, biochemically and if required genetically (e.g. diagnostic PCR). Samples will be scored for presence of bacteria, the total colony forming units and species present.
Timepoint [8] 304872 0
Tips cultured on device removal on clinical suspicion of infection plus a random subset of 10% of devices.
Secondary outcome [9] 304873 0
Patient and staff satisfaction ranked on a 10-point scale
Timepoint [9] 304873 0
At device removal or within 24 hours of removal
Secondary outcome [10] 304874 0
Costs
Timepoint [10] 304874 0
Direct costs to the hospital for the total episode of care, including costs of device and dressing replacement in addition to the effects of dressing choice

Eligibility
Key inclusion criteria
1. Informed written consent
2. CVAD to be inserted for clinical care (includes peripherally inserted central catheters, percutaneous central catheters, tunnelled central catheters).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current bloodstream infection
2. Non-English speaking patients without interpreter
3. CVADS inserted through diseased, burned or scarred skin
4. Current skin tear/'paper' skin at high risk of tear
5. Known allergy to any study product
6. Extremely diaphoretic patients

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 anaesthetist, surgeon or intensivist. 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 stratified by hospital site. 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
N/A
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. 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, colonisation, infection, CVAD breakage, patient/staff satisfaction scores and adverse events will be compared between groups using parametric/nonparametric techniques as appropriate. In addition to group, multivariate regression (Cox) models will test the effect of patient and device variables associated on CVAD failure e.g. insertion site, number of lumens, length of stay, diagnostic group, severity of illness, age, gender, mobility, consciousness and delirium status. Data will be exported into PASW 18.0 (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: We hypothesise a difference (reduced failure rate) of each of three alternative treatments against control. For each, we will measure difference in outcomes for pairs of treatments (i.e. Group (G)1 (BPU – controls) vs G2; G1 vs G3; G1 vs G4 - that is, in turn the three alternatives vs the control). Sample sizes were calculated for three X inequality tests of two proportions. Previous research in the area has reported failure rates of between 20-40% using standard treatment. We are conservatively hypothesising that TA/absorbent/SSD will reduce failure by an absolute proportion of 5%, from 10%. Data from >10,000 patients showed a larger reduction (to 20%), however this was a manufacturer sponsored non-randomised trial and we do not anticipate as large a margin. An absolute reduction in failure of 5% is clinically important. PASS was used to calculate the sample required to reduce the 10% device failure rate (controls) to 5% in each of the three experimental groups with 90% power at p=0.05. This results in each group requiring 582 patients i.e. total of 2,328 CVADs. We will add 5% to allow for attrition, therefore 2,444 patients in total. We plan on undertaking pilot studies to further inform these sample size calculations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/12/2013
Actual
2/09/2013
Date of last participant enrolment
Anticipated
Actual
8/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
2444
Accrual to date
Final
221
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1543 0
The Prince Charles Hospital - Chermside

Funding & Sponsors
Funding source category [1] 288039 0
University
Name [1] 288039 0
Griffith University
Country [1] 288039 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus,
170 Kessels Road,
Nathan, QLD 4111
Country
Australia
Secondary sponsor category [1] 286763 0
None
Name [1] 286763 0
Address [1] 286763 0
Country [1] 286763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289964 0
Children's Health Services Human Research Ethics Committee
Ethics committee address [1] 289964 0
Ethics committee country [1] 289964 0
Australia
Date submitted for ethics approval [1] 289964 0
26/09/2011
Approval date [1] 289964 0
23/11/2011
Ethics approval number [1] 289964 0
HREC/11/QR CH/152

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

Contacts
Principal investigator
Name 43290 0
Prof Claire Rickard
Address 43290 0
NHMRC Centre for Research Excellence in Nursing,
Griffith University
170 Kessels Rd,
Nathan, QLD 4111
Country 43290 0
Australia
Phone 43290 0
+61 7 3735 6460
Fax 43290 0
Email 43290 0
[email protected]
Contact person for public queries
Name 43291 0
Nicole Marsh
Address 43291 0
NHMRC Centre for Research Excellence in Nursing,
Griffith University
170 Kessels Rd,
Nathan, QLD 4111
Country 43291 0
Australia
Phone 43291 0
+61 7 3735 4886
Fax 43291 0
Email 43291 0
[email protected]
Contact person for scientific queries
Name 43292 0
Claire Rickard
Address 43292 0
NHMRC Centre for Research Excellence in Nursing,
Griffith University
170 Kessels Rd,
Nathan, QLD 4111
Country 43292 0
Australia
Phone 43292 0
+61 7 3735 6460
Fax 43292 0
Email 43292 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA 4-arm randomized controlled pilot trial of innovative solutions for jugular central venous access device securement in 221 cardiac surgical patients.2016https://dx.doi.org/10.1016/j.jcrc.2016.06.006
N.B. These documents automatically identified may not have been verified by the study sponsor.