ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

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]

Prevention

Intervention code [2]

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]

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]

At time of CVAD removal, hospital discharge or 4 weeks.

Primary outcome [2]

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]

At conclusion of study

Secondary outcome [1]

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]