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
ACTRN12619000918123
Ethics application status
Approved
Date submitted
20/05/2019
Date registered
1/07/2019
Date last updated
1/07/2019
Date data sharing statement initially provided
1/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Antimicrobial disc (AMD) infection prevention in central venous catheters
Scientific title
Polyhexamethylene biguanide hydrochloride-impregnated antimicrobial discs for infection prevention in central venous catheters: a pilot, randomised controlled trial to assess protocol safety and feasibility.
Secondary ID [1] 297694 0
None
Universal Trial Number (UTN)
Trial acronym
ADORN Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central-line associated bloodstream infection 311985 0
Condition category
Condition code
Infection 310553 310553 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Foam stabilising dressing (ConvaTec EASI-V) and polyurethane dressing (Smith and Nephew IV3000) + Kendall AMD Antimicrobial Foam Disc.
The study and related interventions will be actively implemented whilst the patient has a central venous catheter (CVC) in situ. This will encompass both their time in the intensive care unit, as well as the ward after the patient's ICU discharge. As such, the duration of observation will cease when the CVC is removed (usually no longer than 7 days).
CVCs will be inserted by an appropriately trained inserter as per hospital policy. The study dressings will be applied by clinical staff at time of CVC insertion. Clinical staff will be responsible for the care and maintenance of the CVC as per hospital policy; including dressing changes which will occur every 7 days, or more frequently if clinically indicated due to being soiled, loose or moist. A member of the research team will supply the relevant dressings to bedside clinical staff and extensive education will be given to clinical staff on how to apply, care for and remove the dressings. CVC removal will be at the discretion of the treating team, using usual hospital criteria.
CVCs will be visually assessed every day to assess for patient skin complications. Patients and staff will also be asked to rate their satisfaction with the intervention dressing of the CVC. Additionally, any protocol violations will be recorded.
Intervention code [1] 313924 0
Prevention
Comparator / control treatment
ConvaTec EASI-V dressing + Smith and Nephew IV3000 dressing
Clinical staff will be responsible for the care and maintenance of the CVC as per hospital policy; including dressing changes which will occur every 7 days, or more frequently if clinically indicated due to being soiled, loose or moist. A member of the research team will supply the relevant dressings to bedside clinical staff and extensive education will be given to clinical staff on how to apply, care for and remove the dressings.
Research nurses will monitor CVC insertion sites daily for the duration of the CVC’s dwell time. The research nurse will also follow the patient up at 48 hours post-CVC removal to collect CLABSI and mortality data.
Control group
Active

Outcomes
Primary outcome [1] 319411 0
Feasibility and safety of the study interventions and protocol, as a composite of:
a. Eligibility (% of screened patients meeting all inclusion and no exclusion criteria)
b. Recruitment (% of eligible patients providing informed consent)
c. Retention (% of recruited patients lost to follow up or withdrawing consent)
d. Protocol fidelity (% of randomised patients receiving their allocated intervention)
e. Missing data (% of total data unable to be collected)
f. Patient and staff satisfaction with study intervention/s and control (% of patients and staff scoring >7 on an 11-point Numerical Rating Scale [on application and removal of intervention and control arm dressings])
Timepoint [1] 319411 0
At trial completion.
Secondary outcome [1] 368064 0
Central line-associated bloodstream infection (CLABSI) as defined in the 2019 Centres for Disease Control National Healthcare Safety Network Patient Safety Component Manual Bloodstream Chapter 4: Infection Event (Central Line-Associated Bloodstream Infection and Non-central Line Associated Bloodstream Infection) criteria, and confirmed by an Infectious Diseases specialist.
Timepoint [1] 368064 0
From time of CVC insertion to time of CVC removal.
Secondary outcome [2] 370594 0
Primary bloodstream infection as defined in the 2019 Centres for Disease Control National Healthcare Safety Network Patient Safety Component Manual Bloodstream Chapter 4: Infection Event (Central Line-Associated Bloodstream Infection and Non-central Line Associated Bloodstream Infection) criteria, and confirmed by an Infectious Diseases specialist.
Timepoint [2] 370594 0
From time of CVC insertion to time of CVC removal.
Secondary outcome [3] 370595 0
Venous/arterial infection as defined in the 2019 Centres for Disease Control National Healthcare Safety Network Chapter 17: Surveillance Definitions for Specific Types of Infections criteria (VASC criteria), and confirmed by an Infectious Diseases specialist.
Timepoint [3] 370595 0
From time of CVC insertion to time of CVC removal.
Secondary outcome [4] 370596 0
Skin complications: a composite of any skin complication surrounding the CVC site identified through daily visual inspection of the insertion site, including contact/allergenic dermatitis, pressure injury, skin rash/tears/blisters, pruritus
Timepoint [4] 370596 0
From time of CVC insertion to time of CVC removal.
Secondary outcome [5] 370597 0
Device functional dwell time: time to removal as measured in hours documented on the patients electronic medical records.
Timepoint [5] 370597 0
From time of CVC insertion to time of CVC removal.
Secondary outcome [6] 370598 0
Serious adverse events (death and CVC-related bloodstream infection) as documented in the patient's medical records.
Timepoint [6] 370598 0
From time of CVC insertion to 48 hours after CVC removal.
Secondary outcome [7] 370613 0
Cost-effectiveness (subset of 6 patients per group): dressing cost (as per hospital stores) and number of dressings used (as documented in study data collection forms and confirmed through medical records), cost of staff time for dressing application and replacement (calculated as directly observed time (minutes) x hourly salary).
Timepoint [7] 370613 0
From time of CVC insertion to time of CVC removal.
Secondary outcome [8] 371991 0
Dressing functional dwell time: time in hours to first dressing change as documented on the patients electronic medical records.
Timepoint [8] 371991 0
From time of dressing application to time of dressing removal.

Eligibility
Key inclusion criteria
(1) Greater than or equal to 18 years old.
(2) Requires a CVC for greater than or equal to 72 hours
(3) Informed, written consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Current bloodstream infection (laboratory confirmed within 48 hours of screening)
(2) Concurrent CVC present or anticipated for > 24 hours
(3) Non-English speaking without an interpreter
(4) Previous study enrolment
(5) Known CHG or PHMB allergy
(6) Pre-existing dermatitis/rash/burns at insertion site

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)
Randomisation will be completed via an centralised online randomisation platform.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Data will be exported from the online database to a statistical software package and analysed using intention-to-treat principles. Feasibility outcomes will be reported descriptively. The sample size is not sufficient to determine statistically significant differences in clinical outcomes between groups, which will therefore also be reported descriptively. Means and standard deviations will be reported for normally distributed data, and medians and interquartile ranges will be used to report non-normally distributed data. P values of < 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 hospital [1] 13804 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 26554 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 302218 0
Charities/Societies/Foundations
Name [1] 302218 0
The Prince Charles Hospital Foundation
Address [1] 302218 0
Level 2,
Administration Building
The Prince Charles Hospital
Rode Road
Chermside
QUEENSLAND 4032
Country [1] 302218 0
Australia
Funding source category [2] 302829 0
Other Collaborative groups
Name [2] 302829 0
Australian College of Critical Care Nurses
Address [2] 302829 0
Locked Bag 8
Surrey Hills
VICTORIA 3127
Country [2] 302829 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road
Nathan
QUEENSLAND 4111
Country
Australia
Secondary sponsor category [1] 302777 0
None
Name [1] 302777 0
Address [1] 302777 0
Country [1] 302777 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302898 0
The Prince Charles Hospital HREC
Ethics committee address [1] 302898 0
Building 14
The Prince Charles Hospital
Rode Road
Chermside
QUEENSLAND 4032
Ethics committee country [1] 302898 0
Australia
Date submitted for ethics approval [1] 302898 0
13/03/2019
Approval date [1] 302898 0
02/04/2019
Ethics approval number [1] 302898 0
HREC/2019/PCH/51795

Summary
Brief summary
Central venous catheters (CVCs) are used in most intensive care units (ICU) patients to deliver intravenous treatment and monitor central venous pressures. Whilst integral to patient treatment, CVCs are associated with significant risk, the most serious being infection. Polyhecamethylene buguanide (PHMB)-impregnated foam discs around the CVC insertion site may work to reduce the incidence of CVC infection, but have so far not been tested in a critical care environment.
The aim of this pilot study is to assess feasibility of study protocol and processes to inform budget, sample size calculations and protocol development of a larger, definitive trial.
The outcome measures for this pilot study are feasibility (eligibility, recruitment, retention, protocol fidelity, missing data, patient/staff satisfaction), central line-associated bloodstream infection (CLABSI), other BSIs, venous/arterial infection, skin complications, device/dressing functional dwell time, SAEs and cost-effectiveness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91774 0
Ms Amanda Corley
Address 91774 0
Room 15, Level 3
Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside
QUEENSLAND 4032
Country 91774 0
Australia
Phone 91774 0
+61 7 3139 5772
Fax 91774 0
Email 91774 0
amanda.corley@health.qld.gov.au
Contact person for public queries
Name 91775 0
Miss India Lye
Address 91775 0
Room 15, Level 3
Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside
QUEENSLAND 4032
Country 91775 0
Australia
Phone 91775 0
+61 7 3139 5089
Fax 91775 0
Email 91775 0
india.lye@health.qld.gov.au
Contact person for scientific queries
Name 91776 0
Miss India Lye
Address 91776 0
Room 15, Level 3
Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside
QUEENSLAND 4032
Country 91776 0
Australia
Phone 91776 0
+61 7 3139 5089
Fax 91776 0
Email 91776 0
india.lye@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?
On a 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 (amanda.corley@health.qld.gov.au)
What supporting documents are/will be available?
No other documents available
Summary results
No Results