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Trial registered on ANZCTR


Registration number
ACTRN12616000984493
Ethics application status
Approved
Date submitted
18/07/2016
Date registered
27/07/2016
Date last updated
21/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Secure My Intravascular Line Effectively (SMILE): a pilot randomised controlled trial to evaluate an integrated securement device for peripheral intravenous catheters in medical and surgical patients.
Scientific title
Randomised controlled trial of an integrated securement device (ISD) versus standard care (bordered polyurethane) dressings on intravascular catheter failure in medical and surgical patients.
Secondary ID [1] 289652 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The SMILE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravenous device failure prior to completion of therapy 299450 0
Condition category
Condition code
Public Health 299431 299431 0 0
Health service research
Infection 299520 299520 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in this study have peripheral venous catheters (PVC) used in adult medical and surgical departments. Consenting patients will have their PVC secured with either the intervention or control dressing and securements. This dressing and securement will be applied by either the Research Nurse or the treating clinician (dependent upon who inserts the PVC).

Arm 1 (Control): 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 2 (Intervention): Integrated Securement Device. An Integrated Securement Device is a polyurethane dressing which combines both SP (simple polyurethane) and SD (securement device) into one product.

The randomly allocated dressing will be applied at the time of PVC insertion until device removal. There will be daily checks of the PVC site and dressings/securements to monitor protocol adherence and assess for any complications.
Intervention code [1] 295276 0
Prevention
Intervention code [2] 295353 0
Treatment: Devices
Comparator / control treatment
Control group patients will have their peripheral venous catheters secured with a bordered polyurethane dressing (as per standard care) at the time of PVC insertion until device removal.
Control group
Active

Outcomes
Primary outcome [1] 298901 0
The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for peripheral intravenous catheters. Feasibility measures will include: patient eligibility (more than 80% of those screened); consent (more than 80% agree to enrol); protocol adherence (more than 90% receive the allocated intervention); and retention (less than 5% of enrolled patients lost to follow up).
Timepoint [1] 298901 0
Feasibility measures: At the time of trial completion.
Primary outcome [2] 298903 0
All cause PVC failure A composite of infection (laboratory confirmed local or bloodstream infection), occlusion/infiltration (with or without leakage), dislodgement (complete or partial), phlebitis, or thrombosis (suspected or confirmed). This composite measure incorporates the multifocal path to the same endpoint; PVC failure. These will be assessed by either the Research Nurse (during daily checks); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.
Timepoint [2] 298903 0
At the time of PVC removal.
Secondary outcome [1] 325589 0
Infection (laboratory confirmed local or bloodstream infection): PVC skin and tip samples for culture may be collected by RNs upon PVC removal if clinical suspicion of local infection. Blood cultures may be be collected by RNs throughout the life of the device if clinical suspicion of systemic infection.
Timepoint [1] 325589 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [2] 325590 0
Occlusion/Infiltration: Defined as the PVC will not infuse (occlusion), or the movement of IV fluid into surrounding tissue (infiltration), with or without leakage out of the entry site when fluid is infused.
Timepoint [2] 325590 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [3] 325591 0
Dislodgement (either partial or total):
Partial - Change in PVC length at insertion site (inner catheter visible). This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Total - PVC completely leaves the vein. This will be recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record by the treating clinician.
Timepoint [3] 325591 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [4] 325592 0
Phlebitis: Defined as 2 or more of pain, redness, swelling and a palpable cord. This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [4] 325592 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [5] 325593 0
Thombosis (either suspected on confirmed):
Suspected - This will be assessed by the treating clinician, recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Confirmed - Ultrasound/venographic confirmed thrombosed vessel at the PVC site. This will be assessed by a review of the patient's medical records (including ultrasound findings).
Timepoint [5] 325593 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [6] 325594 0
PVC dwell time: Research staff will calculate time (in hours) from device insertion until removal using relevant information as recorded by clinical staff on a 1 page data collection sheet at the patients bedside and in the patients medical record.
Timepoint [6] 325594 0
At the time of PVC removal.
Secondary outcome [7] 325846 0
Safety and adverse events; Skin reactions related to dressings and securements will be monitored including itch; rash (raised or not raised); blistering; skin tearing; bruising; and pressure areas. This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [7] 325846 0
Daily from PVC insertion until the time of PVC removal. If an adverse event occurs the patient will be monitored until the skin reaction has resolved.
Secondary outcome [8] 325989 0
Staff and patient acceptability of the intervention - assessed on a 0-10 Likert scale.
Timepoint [8] 325989 0
At the time of PVC removal.

Eligibility
Key inclusion criteria
1. Informed written consent
2. PVC in situ
3. PVC scheduled/expected use >24 hours
4. Patient aged 16 years or above.
5, Patient admitted to a Medical or Surgical ward
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known, current bloodstream infection (within 48 hours)
2. Non-English speakers without interpreter
3. PVCs inserted through diseased, burned or scarred skin
4. Other types of vascular access devices
5. Current skin tear/‘papery’ skin at high risk of tear
6. Known allergy to any study product
7. 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)
Research nurses (RNs) will screen patients daily and liaise heavily with the staff responsible for inserting the majority of PVCs (emergency departments, ward-based nurses, 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 log in to a centralised web-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)
Randomisation will be in a 1:1 ratio between the two study groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All randomised patients will be analysed on an Intention to Treat (ITT) basis. The patient is the unit of measurement with one PVC per patient being analysed. We will test the feasibility of the statistical analysis that will be used in the definitive trial. Comparability of groups at baseline will be assessed using clinical parameters. Relative incidence rates of device failure per 100 devices and per 1,000 device days with 95% confidence intervals (CIs) will summarise the impact of each dressing regimen, and to test difference between groups. Kaplan-Meier survival curves (with log rank test) will compare device failure over time. Secondary endpoints including dwell-time, dislodgment, infection and safety will be compared between groups using parametric or nonparametric techniques as appropriate. In addition to group, multivariate regression (Cox) models will test the effect of patient and device variables associated with device failure e.g. insertion site, dwell time, length of stay, diagnostic group, age, sex, mobility, co-morbidities and IV medications. Data will be exported into PASW 22.0 (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 re-entered and checked. 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.

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
Recruitment hospital [1] 6150 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 13590 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 294037 0
Commercial sector/Industry
Name [1] 294037 0
Centurion Medical Products
Address [1] 294037 0
100 Centurion Way
Williamston MI USA 48895
Country [1] 294037 0
United States of America
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road,
Nathan QLD, 4111
Country
Australia
Secondary sponsor category [1] 292858 0
None
Name [1] 292858 0
Not applicable
Address [1] 292858 0
Not applicable
Country [1] 292858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295454 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 295454 0
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane, QLD, 4101
Ethics committee country [1] 295454 0
Australia
Date submitted for ethics approval [1] 295454 0
19/04/2016
Approval date [1] 295454 0
26/05/2016
Ethics approval number [1] 295454 0
HREc/16/QRCH/75
Ethics committee name [2] 295455 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 295455 0
Office for Research
Bray Centre, Nathan Campus
Nathan, QLD, 4111
Ethics committee country [2] 295455 0
Australia
Date submitted for ethics approval [2] 295455 0
26/05/2016
Approval date [2] 295455 0
17/06/2016
Ethics approval number [2] 295455 0
NRS/2016/487

Summary
Brief summary
The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for peripheral intravenous catheters. The RCT aims to (i) identify clinical, cost-effective methods to prevent catheter failure due to infection, phlebitis, occlusion, and dislodgement; (ii) compare usual care dressings with a novel method; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles.

You may be eligible to participate in this trial if you are a medical or surgical patient over the age of 16 and are having a peripheral venous catheter inserted as part of your therapy (which is expected to remain in place for at least 24 hours).

All participants enrolled in this trial will be randomly allocated (by chance) to receive one of two PVC dressing/securement options. This will be either the standard bordered polyurethane dressing; or an integrated securement device. The allocated dressing will be applied from device insertion until the time of device removal. Participants will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, device failures and infections. It is hoped that the findings of this trial will provide information on which PVC securements and dressings are most effective in preventing PVC failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67338 0
Prof Claire Rickard
Address 67338 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 67338 0
Australia
Phone 67338 0
+61 7 37356460
Fax 67338 0
+61 7 37355431
Email 67338 0
c.rickard@griffith.edu.au
Contact person for public queries
Name 67339 0
Ms Emily Larsen
Address 67339 0
Centre for Clinical Nursing (Research and Development Unit)
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 67339 0
Australia
Phone 67339 0
+61 7 36468725
Fax 67339 0
Email 67339 0
emily.larsen@health.qld.gov.au
Contact person for scientific queries
Name 67340 0
Prof Claire Rickard
Address 67340 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 67340 0
Australia
Phone 67340 0
+61 7 37356460
Fax 67340 0
+61 7 37355431
Email 67340 0
c.rickard@griffith.edu.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