The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000026123
Ethics application status
Approved
Date submitted
14/12/2018
Date registered
10/01/2019
Date last updated
26/04/2019
Date data sharing statement initially provided
10/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SECUREment bundles for Peripheral IntraVenous Catheters in general medical and surgical patients: a feasibility trial.
Scientific title
SECUREment bundles for Peripheral IntraVenous Catheters in general medical and surgical patients: Comparing primary dressings with and without additional securement products to prevent device failure (SECURE-PIVC).
Secondary ID [1] 296883 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The SECURE-PIVC Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral intravenous catheter failure prior to completion of treatment 310816 0
Condition category
Condition code
Public Health 309492 309492 0 0
Health service research
Infection 309550 309550 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arms:
1. Intervention group 1
• Control
PLUS
• Sterile tape strip in chevron pattern around hub (Steristrips)
• Sterile tape strip over hub (Steristrips)
• Non-sterile tape over any extension tubing

2. Intervention group 2:
• Intervention group 1
PLUS
• Non-compression tubular bandage (Tubifast 15cm)

The study intervention/s and control intervention will be applied by the PIVC inserter (research nurse and vascular access specialist) as per treatment allocation. After insertion and initial dressing and securement of the PIVC, all PIVCs will be maintained by clinical staff as per hospital policy. This includes: routine review of PIVCs by nursing staff at least once per shift and medical staff at least daily, specifically for the ongoing need for cannula, the state of the dressing, cannula patency and presence of complications; and a regular flushing regime of 5 – 10 mls of 0.9% Sodium Chloride administered using a pulsatile positive pressure technique if no continuous infusion is running. Nurses maintaining the PIVC will be responsible for any dressing changes or additional securement products, and these will be recorded by the research staff. The timing of removal of PIVCs will be determined by the clinical team using usual hospital criteria, namely PIVC complication necessitating removal, 72 hourly resite (it is standard practice in the hospital for PIVCs to be routinely resited at 72 hours), and/or completion of therapy.
Protocol adherence will be collected daily by the research nurse and described descriptively as per the primary outcome. Extensive education sessions and written materials will be provided to staff to enhance protocol adherence.
Intervention code [1] 313157 0
Prevention
Intervention code [2] 313158 0
Treatment: Devices
Comparator / control treatment
Control arm:
PIVCs will be dressed and secured as per standard practice at the Royal Brisbane and Woman’s Hospital (RBWH) which is currently:
- Bordered polyurethane dressing (Tegaderm™ IV)
- Non-sterile tape over extension tubing (Micropore)

The study intervention/s and control intervention will be applied by the PIVC inserter as per treatment allocation. After insertion and initial dressing and securement of the PIVC, all PIVCs will be maintained by clinical staff as per hospital policy. This includes: routine review of PIVCs by nursing staff at least once per shift and medical staff at least daily, specifically for the ongoing need for cannula, the state of the dressing, cannula patency and presence of complications; and a regular flushing regime of 5 – 10 mls of 0.9% Sodium Chloride administered using a pulsatile positive pressure technique if no continuous infusion is running. Nurses maintaining the PIVC will be responsible for any dressing changes or additional securement products, and these will be recorded by the research staff. The timing of removal of PIVCs will be determined by the clinical team using usual hospital criteria, namely PIVC complication necessitating removal, 72 hourly resite(it is standard practice in the hospital for PIVCs to be routinely resited at 72 hours), and/or completion of therapy.

Control group
Active

Outcomes
Primary outcome [1] 308447 0
The primary outcome will be one of feasibility, as determined by the following criteria:
• Eligibility (greater than or equal to 90% of potentially screened participants eligible),
• Recruitment (greater than or equal to 90% of eligible participants provide informed consent),
• Retention (<5% of participants lost to follow up).
• Protocol fidelity (greater than or equal to 80% of participants receive the allocated intervention)
• Missing data (<5% of available outcome data unable to be collected)
• Patients and clinical staff score the intervention arm/s greater than or equal to 7 on an 11 point Numerical Rating Scale of satisfaction and acceptability (>80% satisfaction and acceptability)
• Sample size calculations calculated for an adequately powered study, based on incidence rates and their 95% confidence intervals observed in the pilot RCT.
For the primary outcome of feasibility, data regarding eligibility and recruitment will be gained from the screening log which will contain 1) all patients screened for study inclusion, regardless of whether they met the eligibility criteria, 2) recruitment status, and 3) treatment allocation. Data for the remaining feasibility outcomes (retention, protocol fidelity, missing data, and patient and staff satisfaction) will be held in the REDCap database and analysed from there.
Timepoint [1] 308447 0
At the time of trial completion
Secondary outcome [1] 354986 0
PIVC failure, as a composite measure of any of the following complications resulting in premature device removal before the end of therapy:
a. Phlebitis (two or more of pain, tenderness, warmth, erythema, swelling, palpable cord) [1]
b. Infiltration (permeation of intravenous fluid into the interstitial compartment, causing swelling of the tissue around the site of the catheter) [1]
c. Occlusion (PIVC will not infuse or flush or leakage occurs when fluids infused/flushed) [2]
d. Accidental dislodgement/removal (partial or complete dislodgement from vein) [3]
e. Peripheral Line Associated Bloodstream Infection, laboratory confirmed (from blood collected as part of routine care) in accordance with one of the following criteria [4]:
1. a recognized pathogen, identified from one or more blood specimens obtained by a culture or non-culture based microbiologic testing method AND Organism(s) identified in blood is not related to an infection at another site
2. Patient has at least one of the following signs or symptoms: fever (>38.0oC), chills, or hypotension AND Organism(s) identified in blood is not related to an infection at another site AND The same Centres of Disease Control National Health and Safety Network common commensal is identified by a culture or non-culture based microbiologic testing method, from two or more blood specimens collected on separate occasions
f. Local infection at the PIVC insertion site (as defined by meeting at least one of the following criteria) [4]
1. Patient has at least one of the following signs or symptoms: fever (>38.0°C), pain, erythema, or heat at the PIVC insertion vascular site AND More than 15 colonies cultured from intravascular cannula tip using semi-quantitative culture method.
2. Patient has purulent drainage at PIVC site

References for outcome measures:
1. Webster J, Clarke S, Paterson D, Hutton A, van Dyk S, Gale C, et al. Routine care of peripheral intravenous catheters versus clinically indicated replacement: randomised controlled trial. Br Med J (Clin Res Ed). 2008;337:a339.
2. Rickard CM, Marsh N, Webster J, Playford EG, McGrail MR, Larsen E, et al. Securing All intraVenous devices Effectively in hospitalised patients--the SAVE trial: study protocol for a multicentre randomised controlled trial. BMJ Open. 2015;5(9):e008689.
3. Rickard C, Marsh N, Webster J, Runnegar N, Larsen E, McGrail M, et al. Dressings and securements for the prevention of peripheral intravenous catheter failure (SAVE Trial) in adults: a pragmatic, randomised, controlled, superiority trial. Lancet. 2018;392(10145):419-30.
4. Centers of Disease Control and Prevention. National Healthcare Safety Network (NHSN) Patient Safety Component Manual. Washington, DC: Centers of Disease Control and Prevention; 2018.
Timepoint [1] 354986 0
Daily from PIVC insertion until the time of PIVC removal.
Secondary outcome [2] 354987 0
PIVC dwell time (The time of PIVC insertion and PIVC removal will be collected by the research nurse from the patients medical record and the time in hours between these two points will be calculated)
Timepoint [2] 354987 0
From the time of PIVC insertion to removal (in hours)
Secondary outcome [3] 354988 0
Skin adverse events (rash, blister, itchiness, skin tears, adhesive residue).

The research nurse will visually assess the insertion site and dressings daily to collect this data. Education will be provided to the research nurses prior to commencement of the study so that they can accurately identify and document skin adverse events. Additionally, inter-rater reliability testing between the researcher will be performed for 5% of the daily site inspections to ensure reliability of outcome assessment.
Timepoint [3] 354988 0
Daily from PIVC insertion until the time of PIVC removal.
Secondary outcome [4] 354989 0
PIVC site and device colonisation: On PIVC removal, a subset of 6 patients per arm will have their PIVC and an insertion site swab collected to assess site and device colonisation.
Timepoint [4] 354989 0
On PIVC removal
Secondary outcome [5] 354990 0
Cost analysis: in a subset of 6 patients per study group, resources utilised (staff time, consumables) during PIVC insertion, application or reapplication of study intervention, and removal will be recorded. The cost of treating any complications associated with the PIVC dwell will also be recorded.
Timepoint [5] 354990 0
From PIVC insertion until the time of PIVC removal.

Eligibility
Key inclusion criteria
• 18 years or over
• Requires a PIVC for > 24 hours
• Ability to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-English speaking without an interpreter
• Current BSI (within 24 hours of screening), with the exclusion of a single common skin contaminant (Reference: Centers of Disease Control and Prevention. National Healthcare Safety Network (NHSN) Patient Safety Component Manual. Washington, DC: Centers of Disease Control and Prevention, 2019)
• Known allergy to any study product
• Current skin tear, or deemed at high risk of skin tear by PIVC inserter
• Previous recruitment to 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)
Allocation will be concealed until time of web-based central randomisation service. Participants will not be randomised until just prior to PIVC insertion and only once the patient is randomised will treatment allocation be revealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be computer generated in a ratio of 1:1:1, using randomly varied block sizes of 3 and 6 to avoid allocation prediction in addition to uneven group allocation in this small pilot trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The assessor allocating the infection outcomes will be blinded to treatment allocation. Due to the nature of the interventions, it will not be possible to blind the research nurse collecting the outcomes of interest.
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
Trial feasibility outcomes will be reported descriptively and compared against the a priori acceptability limits. All randomised patients will be analysed by intention to treat, regardless of treatment received. Incidence rates of PIVC failure with 95% confidence intervals will summarise the effectiveness of each intervention, and test for group differences. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare device failure over time. Other secondary clinical outcomes will be compared between groups with appropriate parametric or non-parametric techniques. Continuous data will be reported as means (standard deviation) or median (interquartile limits), dependant on normality testing. P values <0·05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
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 postcode(s) [1] 25155 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 301453 0
Other Collaborative groups
Name [1] 301453 0
Australian College of Infection Prevention and Control Cardinal Health Infection Prevention Scholarship 2018
Address [1] 301453 0
ACIPC Ltd
228 Liverpool Street
HOBART TAS 7000
Country [1] 301453 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road,
Nathan QLD, 4111
Country
Australia
Secondary sponsor category [1] 301144 0
None
Name [1] 301144 0
Address [1] 301144 0
Country [1] 301144 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302187 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 302187 0
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street, Herston Qld 4029
Ethics committee country [1] 302187 0
Australia
Date submitted for ethics approval [1] 302187 0
24/08/2018
Approval date [1] 302187 0
16/11/2018
Ethics approval number [1] 302187 0
HREC/2018/QRBW/44571

Summary
Brief summary
Despite the importance of PIVCs to the delivery of patient care, failure and complication rates are unacceptably high. Rates of failure and unscheduled reinsertions due to complications are reported to be between 30 and 69%. Factors responsible for early failure include phlebitis, occlusion, infiltration, extravasation, dislodgement and infection.

PIVC failure is a significant cost to both patients and the health care system. Effective securement of PIVC is paramount to preventing failure and complications however, to date, an optimal dressing and securement combination is yet to be identified and more innovative solutions are required. An evidence gap exists regarding the use of medical adhesive tapes and supplementary securement products in PIVC care.

We will conduct a single centre pilot randomised controlled trial (RCT) to assess the feasibility of conducting a large scale RCT testing PIVC securement bundles against standard care to prevent PIVC failure and complications. The primary aim of this study is to establish feasibility of the protocol and the planned processes. This will help to budget and plan correctly for the larger definitive trial. We will collect data on the success of screening and recruitment strategies; test our data collection processes and technology; cost the Research Nurse time required for the trial; and finalise sample size requirements for the larger trial.

Participants will be eligible for inclusion in this trial if they are a medical or surgical patient over the age of 18 and are having a peripheral intravenous catheter inserted as part of their 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 have their PVC dressed and secured with either standard care (control) or one of two securement bundles (intervention). Daily follow ups will then be carried out by a Research Nurse until the time of device removal.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 89414 0
Ms Amanda Corley
Address 89414 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 89414 0
Australia
Phone 89414 0
+61 7 3139 5772
Fax 89414 0
Email 89414 0
amanda.corley@health.qld.gov.au
Contact person for public queries
Name 89415 0
Ms Amanda Corley
Address 89415 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 89415 0
Australia
Phone 89415 0
+61 7 3139 5772
Fax 89415 0
Email 89415 0
amanda.corley@health.qld.gov.au
Contact person for scientific queries
Name 89416 0
Ms Amanda Corley
Address 89416 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 89416 0
Australia
Phone 89416 0
+61 7 3139 5772
Fax 89416 0
Email 89416 0
amanda.corley@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
case-by-case basis at the discretion of Principal Investigator
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator
What supporting documents are/will be available?
No other documents available
Summary results
No Results