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Trial registered on ANZCTR


Registration number
ACTRN12616000027415
Ethics application status
Approved
Date submitted
6/11/2015
Date registered
15/01/2016
Date last updated
15/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Central venous Access device SeCurement And Dressing Effectiveness (CASCADE) for peripherally inserted central catheters: a pilot, randomised controlled trial
Scientific title
Randomised controlled trial of tissue adhesive, absorbent dressing, combined securement and dressing product versus standard care dressings to prevent peripherally inserted central catheter failure in acute care adult patients: The CASCADE PICC trial
Secondary ID [1] 287816 0
Nil
Universal Trial Number (UTN)
U1111-1176-2669
Trial acronym
The CASCADE PICC trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous access device failure prior to completion of therapy 296694 0
Condition category
Condition code
Public Health 296929 296929 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in this study have peripherally inserted central catheters (PICCs) in medical, surgical, anaesthetic and intensive care departments.. Patients or substitute decision makers (if appropriate) will have their PICCs 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: Combined securement and dressing product: extra-reinforced borders, with an absorbent layer around the polyurethane claimed to ‘wick’ moisture away from the wound. A chlorhexidine-impregnated disc will also be used.
Arm 3: An absorbent polyurethane dressing: a tri-layer dressing made up of a low adherent wound contact layer, a lattice shaped absorbent pad and a top film that is waterproof and is coated with a water-based adhesive. A chlorhexidine-impregnated disc is also to be used.
Arm 4 (Control): Sutureless Stabilisation Device (SSD) have a large adhesive padded footplate with locking clasp made of hard plastic. SSD are used in addition to polyurethane dressing and a chlorhexidine-impregnated disc.

The randomly allocated dressing will be applied until completion of therapy, hospital discharge or at four dressing changes. The dressing will be applied at PICC insertion and then changed every 7 days, or on disruption of the dressing integrity.
Intervention code [1] 293206 0
Prevention
Intervention code [2] 293207 0
Treatment: Devices
Comparator / control treatment
Arm 4 (Control): Sutureless Stabilisation Device (SSD) have a large adhesive padded footplate with locking clasp made of hard plastic. SSD are used in addition to polyurethane dressing and a chlorhexidine-impregnated disc.
Control group
Active

Outcomes
Primary outcome [1] 296541 0
Primary Outcome: 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 PICC failure or
complication (defined in the secondary outcomes) by at least 5% in the
experimental arms, in comparison to standard care.
Timepoint [1] 296541 0
At completion of the study
Primary outcome [2] 296542 0
PICC failure or complication:
Composite measure of any reason for unplanned PICC 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 [2] 296542 0
At time of PICC removal, hospital discharge or 4 dressing changes.
Secondary outcome [1] 318709 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] 318709 0
At time of PICC removal, hospital discharge or 4 dressing changes
Secondary outcome [2] 318710 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] 318710 0
At time of removal, hospital discharge or 4 dressing changes.
Secondary outcome [3] 318711 0
Dislodgement:
Partial: any post-insertion change in the length of the PICC body from
the hub to the PICC tip, as measured by the catheter marking in closest approximation to hub.
Total: PICC body completely leaves the vein, or must be removed
because PICC tip is no longer in the superior vena cava (diagnosed by
XRay/leakage from site on injection/clinician diagnosis)
Timepoint [3] 318711 0
At time of removal, hospital discharge or 4 dressing changes
Secondary outcome [4] 318712 0
Occlusion:
>/=1 lumen unable to be flushed/aspirated, diagnosed by treating
clinician
Timepoint [4] 318712 0
At time of removal, hospital discharge or 4 dressing changes
Secondary outcome [5] 318713 0
PICC breakage:
Visible split in PICC material diagnosed by treating clinician
Timepoint [5] 318713 0
At time of removal, hospital discharge of 4 weeks.
Secondary outcome [6] 318714 0
Dressing/securement failure:
Early replacement before seven days for loose, soiled or missing
dressings
Timepoint [6] 318714 0
At seven days after dressing application
Secondary outcome [7] 318715 0
PICC dwell time, and dressing dwell time:
Time in hours/days from insertion/application until removal
Timepoint [7] 318715 0
At time of PICC removal
Secondary outcome [8] 318716 0
Frequency of local site damage including irritation, redness, inflammation
Timepoint [8] 318716 0
At device removal, at hospital discharge or 4 dressing change
Secondary outcome [9] 318717 0
Patient and staff satisfaction and acceptability ranked on a 10-point
scale
Timepoint [9] 318717 0
At device removal, at hospital discharge or 4 dressing changes

Eligibility
Key inclusion criteria
*Patients 16 years of age or above
*PICCs to be inserted for clinical care
*Informed consent to participate
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Current bloodstream infection
*Non-English speakers without interpreter
*PICCs inserted through diseased, burned or scarred skin
*Other types of central venous access devices other than PICCs
*Current skin tear/‘papery’ skin at high risk of tear
*Known allergy to any study product
*Previous enrolment in the current study

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 (ReN) will screen patients daily (screening log kept), gain informed consent, and perform randomisation. The ReN will have the study products in pre-packs and liaise closely with the ordering and inserting surgeon. All elligible patients (or their representative) will be approached for written informed consent by the ReN 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 PICC 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 PICC 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 PICC failure over time. Secondary endpoints including dwell-time, costs, dislodgement, occlusion, breakage, patient/staff
satisfaction scores and adverse events will be compared between groups using parametric/nonparametric techniques as appropriate.

Data will be exported into STATA. 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. Forty participants per study arm will be recruited - totaling 160 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

Funding & Sponsors
Funding source category [1] 292339 0
Charities/Societies/Foundations
Name [1] 292339 0
Royal Brisbane and Women's Hospital Foundation
Address [1] 292339 0
Butterfield Street,
Herston, Queensland 4029
Country [1] 292339 0
Australia
Funding source category [2] 292340 0
Commercial sector/Industry
Name [2] 292340 0
Centurion Medical Products
Address [2] 292340 0
100 Centurion Way
Williamstown, MI 48895
United States
Country [2] 292340 0
United States of America
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street, Herston, Queensland 4029
Country
Australia
Secondary sponsor category [1] 291019 0
None
Name [1] 291019 0
None
Address [1] 291019 0
None
Country [1] 291019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293805 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 293805 0
Royal Brisbane and Women's Hospital
Level 7 Block 7
Butterfield Street, Herston
Queensland 4029
Ethics committee country [1] 293805 0
Australia
Date submitted for ethics approval [1] 293805 0
20/11/2013
Approval date [1] 293805 0
10/02/2014
Ethics approval number [1] 293805 0
HREC/13/QRBW/454

Summary
Brief summary
Adults admitted to an acute care facility frequently require the insertion of a peripherally inserted central catheter (PICC) for the administration of medication and fluids. These PICCs are associated with a high rate of failure, including PICC-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU) and sutureless securement devices (SSD), are used to protect the PICC insertion site from contamination. Additional securement devices, such as sutures, are used to reduce movement of the catheter.
New products, including tissue adhesive (TA), absorbent dressings, and combined securement and dressing products (CSD), are available to clinicians to provide securement and dressings for PICC. It is not known whether these new products are effective at reducing PICC failure and complication, in comparison to standard care.

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 PICC failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for adults with PICC in acute care.
Trial website
Trial related presentations / publications
The data collection was completed, however, we are still in the process of analysing data and completing the report.
Public notes

Contacts
Principal investigator
Name 61390 0
A/Prof Raymond Chan
Address 61390 0
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Butterfield Street, Herston
Queensland 4029
Country 61390 0
Australia
Phone 61390 0
+61 4 29 192 127
Fax 61390 0
Email 61390 0
raymond.chan@health.qld.gov.au
Contact person for public queries
Name 61391 0
A/Prof Raymond Chan
Address 61391 0
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Butterfield Street, Herston
Queensland 4029
Country 61391 0
Australia
Phone 61391 0
+61 4 29 192 127
Fax 61391 0
Email 61391 0
raymond.chan@health.qld.gov.au
Contact person for scientific queries
Name 61392 0
A/Prof Raymond Chan
Address 61392 0
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Butterfield Street, Herston
Queensland 4029
Country 61392 0
Australia
Phone 61392 0
+61 4 29 192 127
Fax 61392 0
Email 61392 0
raymond.chan@health.qld.gov.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