Central venous Access device SeCurement And Dressing Effectiveness (CASCADE) for peripherally inserted central catheters: a pilot, randomised controlled trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000027415
• Date of registration: 15/01/2016
• Prospective Registration: No
• Primary sponsor: Royal Brisbane and Women's Hospital
• 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
• Date of first enrolment: 01/03/2014
• Target sample size: 160
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000027415.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: A/Prof Raymond Chan

• Name: A/Prof Raymond Chan

Key inclusion & exclusion criteria

Inclusion criteria: *Patients 16 years of age or above
*PICCs to be inserted for clinical care
*Informed consent to participate
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

Age minimum: 16 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Health service research

Central venous access device failure prior to completion of therapy;
Central venous access device failure prior to completion of therapy

Intervention(s)

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.

Primary Outcome(s)

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[At time of PICC removal, hospital discharge or 4 dressing changes.]

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.[At completion of the study]

Secondary Outcome(s)

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. [At time of PICC removal, hospital discharge or 4 dressing changes]

Occlusion:
>/=1 lumen unable to be flushed/aspirated, diagnosed by treating
clinician[At time of removal, hospital discharge or 4 dressing changes]

Patient and staff satisfaction and acceptability ranked on a 10-point
scale[At device removal, at hospital discharge or 4 dressing changes]

Frequency of local site damage including irritation, redness, inflammation[At device removal, at hospital discharge or 4 dressing change]

Local infection of the skin:
Purulent discharge, or redness extending 1cm beyond the site that
prompts clinician to order removal, or commence antimicrobial therapy.[At time of removal, hospital discharge or 4 dressing changes.]

Dressing/securement failure:
Early replacement before seven days for loose, soiled or missing
dressings[At seven days after dressing application]

PICC breakage:
Visible split in PICC material diagnosed by treating clinician[At time of removal, hospital discharge of 4 weeks.]

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)[At time of removal, hospital discharge or 4 dressing changes]

PICC dwell time, and dressing dwell time:
Time in hours/days from insertion/application until removal[At time of PICC removal]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Royal Brisbane and Women's Hospital Foundation

Centurion Medical Products

Ethics review

Status: Approved
Approval date:
Contact:

Royal Brisbane and Women's Hospital Human Research Ethics Committee