Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000769987
Ethics application status
Approved
Date submitted
20/07/2011
Date registered
22/07/2011
Date last updated
29/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Securing Arterial and Venous devices Effectively in hospitals (The SAVE trial)
Scientific title
Randomised controlled trial of tissue adhesive, bordered polyurethane, or external stabilisation devices versus standard care (standard polyurethane) dressings to prevent intravascular device failure in hospital patients with intravenous and arterial devices: The SAVE Trial
Secondary ID [1] 262668 0
Nil
Universal Trial Number (UTN)
U1111-1122-9449
Trial acronym
The SAVE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravenous and arterial device failure prior to completion of therapy 268373 0
Condition category
Condition code
Public Health 268508 268508 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in this study have intravascular devices (IVDs) used in medical, surgical, anaesthetic and intensive care departments, and include adult and paediatric patients. Consenting patients will have their IVD secured with one of the following randomly assigned dressings and securements:

Arm 1: Tissue Adhesive. Tissue Adhesive (TA) is medical grade ‘superglue’ (cyanoacrylate) used mainly to close skin lacerations/wounds as an alternative to sutures and staples.

Arm 2: Bordered Polyurethane dressing. Bordered polyurethane dressings (BPUs) retain the central polyurethane component of standard polyurethane dressings with an added external adhesive border of foam or cloth fabric.

Arm 3: Sutureless Securement Device. Sutureless Stabilization Devices (SSD) are used in addition to SPUs. They have a large adhesive footplate underlying a pad on the skin plus an Intravascular Device-locking clasp, or

Arm 4 (Control): Standard Polyurethane dressing. Standard Polyurethane dressings (SPUs) are commercially-made plastic film dressings which are transparent and semi-permeable (to oxygen, carbon dioxide and water vapour).

The randomly allocated dressing will be applied until completion of therapy.
Intervention code [1] 267012 0
Prevention
Comparator / control treatment
Control group patients will have their intravascular devices secured with standard polyurethane (SPU) dressings (as per usual care) until completion of therapy
Control group
Active

Outcomes
Primary outcome [1] 269253 0
IVD failure.

Composite of any unplanned IVD removal, prior to completion of therapy. This includes dislodgement (complete), occlusion (IVD will not infuse, or leakage occurs when fluid infused), phlebitis (2 or more of pain, redness, swelling and a palpable cord), and infection (laboratory confirmed local or bloodstream infection). A composite measure was chosen since IVD failure is the outcome of importance to patients, with poor securement taking various pathways to the same endpoint.

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] 269253 0
At the time of IVD removal.
Secondary outcome [1] 279220 0
IVD dwell time.

Research staff will calculate Time in hours from insertion until removal using relevant information as recorded by clinical staff on a 1 page data collection sheet at the patient?s bedside and in the patient?s medical record.
Timepoint [1] 279220 0
At the time of IVD removal.
Secondary outcome [2] 279221 0
Costs. Direct costs to the hospital for the total episode of care, including costs of device replacement in addition to the effects of dressing choice.
Timepoint [2] 279221 0
For the period of hospitalisation
Secondary outcome [3] 279222 0
Types of IVD failure. Analysed as secondary outcomes (dislodgement, occlusion, phlebitis, and infection).

Clinical staff will visually inspect IVDs at removal and identify reason for IVD failure documenting same in patient medical record and on study data collection sheet. This is an objective measure, easily assigned by clinical staff (not research staff or investigators). This is routine clinical practice. Research staff will collect the secondary endpoint from the medical records with additional information obtained from the clinical staff/patients if required.
Timepoint [3] 279222 0
At time of IVD removal
Secondary outcome [4] 279223 0
Device colonisation (>15cfu).

IVD cultures will be performed by the RNs on IVD removal. IVD 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 [4] 279223 0
Tips cultured on device removal on clinical suspicion of infection plus a random subset of 10% of devices
Secondary outcome [5] 279224 0
Skin colonisation (>15cfu) from a random 10% subset of devices.

Skin cultures will be performed by the RNs on IVD removal. Moistened sterile swabs will be used to swab skin at the IVD wound and then placed in transport media. Samples will be transferred to the laboratory, where swabs will be streaked onto non-selective agar. 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 [5] 279224 0
Whilst IVD in situ and on device removal
Secondary outcome [6] 279225 0
Patient and staff satisfaction ranked on a 10 point scale
Timepoint [6] 279225 0
At device removal or within 24 hours of removal

Eligibility
Key inclusion criteria
1. Informed written consent
2. Intravenous or arterial IVD in situ.
3. IVD scheduled/expected use > 24 hours
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-English speaking patients without interpreter
2. IVD inserted through burned or diseased skin
3. Extremely diaphoretic patients
4. Known allergy to any study product

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)
Research nurses (RNs) will screen patients daily and liaise heavily with the staff responsible for inserting the majority of IVDs (emergency departments, IVD insertion services, intensive care, medical registrars and anaesthetists). All eligible patients (or their representative) will be approached for written informed consent by the RN or inserter. If this is given, the staff member will ring a telephone-based, randomisation service customised for the trial and be advised of group allocation. Computer generated allocation is provided by an independent 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 device type (venous or arterial IVD) and by hospital site. Randomisation will be in a 1:1:1:1 ratio between the four study groups. Block randomisation will be used with random variation in block size.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2011
Actual
8/05/2012
Date of last participant enrolment
Anticipated
Actual
12/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
2128
Accrual to date
Final
2158
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1612 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 1613 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 3968 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 267489 0
University
Name [1] 267489 0
Griffith University
Country [1] 267489 0
Australia
Funding source category [2] 288163 0
Government body
Name [2] 288163 0
National Health and Medical Research Council
Country [2] 288163 0
Australia
Funding source category [3] 291533 0
Government body
Name [3] 291533 0
Qld Health Centre for Healthcare Improvement Office of Health and Medical Research Nursing & Midwifery Project Grants
Country [3] 291533 0
Australia
Funding source category [4] 291534 0
Charities/Societies/Foundations
Name [4] 291534 0
The Prince Charles Hospital Foundation
Country [4] 291534 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus,
170 Kessels Road,
Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 266533 0
None
Name [1] 266533 0
Address [1] 266533 0
Country [1] 266533 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269458 0
Queensland Children's Health Service District Human Research Ethics Committee
Ethics committee address [1] 269458 0
Ethics committee country [1] 269458 0
Australia
Date submitted for ethics approval [1] 269458 0
14/09/2011
Approval date [1] 269458 0
23/11/2011
Ethics approval number [1] 269458 0
HREC/11/QRCH/152

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

Contacts
Principal investigator
Name 32901 0
Prof Claire Rickard
Address 32901 0
NHMRC Centre for Research Excellence in Nursing, Griffith University 170 Kessels Road, Nathan QLD 4111
Country 32901 0
Australia
Phone 32901 0
+61 7 37356460
Fax 32901 0
+61 7 37355431
Email 32901 0
[email protected]
Contact person for public queries
Name 16148 0
Ms Nicole Marsh - Project Manager
Address 16148 0
Royal Brisbane and Women's Hospital,
Centre for Clinical Nursing (Research & Development Unit,
Level 2, Building 34
Herston
QLD 4029
Country 16148 0
Australia
Phone 16148 0
+61 7 36365833
Fax 16148 0
Email 16148 0
[email protected]
Contact person for scientific queries
Name 7076 0
Professor Claire Rickard
Address 7076 0
NHMRC Centre for Research Excellence in Nursing,
Griffith University
170 Kessels Road,
Nathan QLD 4111
Country 7076 0
Australia
Phone 7076 0
+61 7 37356460
Fax 7076 0
+61 7 37355431
Email 7076 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
Dimensions AIA pilot trial of bordered polyurethane dressings, tissue adhesive and sutureless devices compared with standard polyurethane dressings for securing short-term arterial catheters2014https://doi.org/10.1016/s1441-2772(23)01469-2
EmbaseSecurement methods for peripheral venous catheters to prevent failure: A randomised controlled pilot trial.2015https://dx.doi.org/10.5301/jva.5000348
EmbaseDressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): a pragmatic, randomised controlled, superiority trial.2018https://dx.doi.org/10.1016/S0140-6736%2818%2931380-1
N.B. These documents automatically identified may not have been verified by the study sponsor.