Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001120561
Ethics application status
Approved
Date submitted
7/07/2015
Date registered
23/10/2015
Date last updated
7/07/2020
Date data sharing statement initially provided
18/12/2018
Date results information initially provided
17/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating methods for effective decontamination of needleless connectors in adult patients: A pilot randomised control trial
Scientific title
Can a chlorhexidine in a 70% alcohol swab, a 70% alcohol impregnated cap, or the standard treatment of a 70% alcohol swab, be used for effective decontamination of needleless connectors in an adult patient population: A pilot randomised control trial?
Secondary ID [1] 287049 0
Nil
Universal Trial Number (UTN)
Trial acronym
DINAMIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Needleless connector care and maintenance 295530 0
Bloodstream infection 295653 0
Condition category
Condition code
Infection 295803 295803 0 0
Other infectious diseases
Public Health 295805 295805 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: Decontamination of the needleless connector using a 2% chlorhexidine and 70% alcohol swab

Intervention 2: Decontamination of the needleless connector with the use of a 70% alcohol impregnated cap that is screwed into place on the needleless connector, and remains in place until nursing staff are required to inject medications into the connector. The cap is discarded, and a new one applied once treatment has been completed. The cap can stay in position for up to one week, and is required to be in position for at least 5 minutes prior to decontamination taking effect.

Overall duration of the intervention will be from device insertion through to device removal, or up to 4 weeks from time of recruitment (whichever comes first).
The frequency of decontamination will be each time the connector is accessed.
Ward nursing staff will be administering the intervention.
Adherence to the intervention will be monitored by a Research nurse twice weekly to assess compliance.
Intervention code [1] 292272 0
Prevention
Intervention code [2] 292273 0
Treatment: Devices
Comparator / control treatment
The control: Decontamination of the needleless connector using a 70% alcohol swab (current practice).

This treatment is current standard practice.
Overall duration of the intervention will be from device insertion to device removal, or up to 4 weeks from time of recruitment (whichever comes first).
The frequency of decontamination will be each time the connector is accessed.
Ward nursing staff will be administering the intervention.
Adherence to the intervention will be monitored by a Research nurse twice weekly to assess compliance.
Control group
Active

Outcomes
Primary outcome [1] 295502 0
The composite primary outcome of this pilot trial is to assess: feasibility (eligibility (proportion of screened patients eligible >80%), recruitment (proportion of eligible patients recruited >80%), retention and attrition (<5%), protocol adherence (>90%), missing data, staff satisfaction); data collection strategies; proposed methods; and to test the interventions with the control to determine an appropriate size for a future larger clinical trial.
Timepoint [1] 295502 0
At the completion of the research study
Secondary outcome [1] 315714 0
Central line-associated bloodstream infection: as defined by CDC/NHSN criteria.
This will be confirmed by a blinded infectious diseases specialist using de-identified clinical and microbiological data.
Timepoint [1] 315714 0
Between the time of device insertion and 48 hours after device removal, or patient removal from study, whichever comes first.
Secondary outcome [2] 315716 0
Mortality
Timepoint [2] 315716 0
Patients will be assessed for outcomes 48 hours after device removal, or patient removal from study, whichever comes first.
Secondary outcome [3] 374450 0
Primary bloodstream infection (laboratory confirmed bloodstream infection): as defined by CDC/NHSN criteria.
This will be confirmed by a blinded infectious diseases specialist using de-identified clinical and microbiological data.
Timepoint [3] 374450 0
Between the time of device insertion and 48 hours after device removal, or patient removal from study, whichever comes first.
Secondary outcome [4] 374451 0
Device (tip) colonisation: defined as a positive tip culture (equal to or more than 15 colony forming units). (Note. device tips will be removed upon suspicion of infection by the treating clinical team, not research staff).
Timepoint [4] 374451 0
Upon removal of the central line.

Eligibility
Key inclusion criteria
Patients greater than or equal to 18 years of age
Requiring a CVAD to be inserted for greater than or equal to seven days
Able to provide informed consent
CVAD inserted within 24 hours of recruitment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking without an interpreter
Current bloodstream infection
Previous enrolment in the study in current hospital admission

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)
Computer generated allocation.

Allocation is concealed by a central randomisation computer service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2017
Actual
31/07/2017
Date of last participant enrolment
Anticipated
28/06/2019
Actual
5/04/2019
Date of last data collection
Anticipated
26/07/2019
Actual
11/04/2019
Sample size
Target
200
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4017 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 12039 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 9941 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 24196 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 291611 0
University
Name [1] 291611 0
Griffith University
Country [1] 291611 0
Australia
Funding source category [2] 300822 0
Charities/Societies/Foundations
Name [2] 300822 0
Cancer Council Queensland
Country [2] 300822 0
Australia
Funding source category [3] 300823 0
Government body
Name [3] 300823 0
Nursing and Midwifery Research Fellowship
Country [3] 300823 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road
Nathan
Queensland, 4111
Country
Australia
Secondary sponsor category [1] 290282 0
Hospital
Name [1] 290282 0
Royal Brisbane and Women's Hospital
Address [1] 290282 0
Butterfield Street
Herston
Queensland, 4029
Country [1] 290282 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293144 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 293144 0
Butterfield Street
Herston
Queensland, 4029
Ethics committee country [1] 293144 0
Australia
Date submitted for ethics approval [1] 293144 0
16/11/2015
Approval date [1] 293144 0
11/12/2015
Ethics approval number [1] 293144 0
Ethics committee name [2] 304233 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 304233 0
Office for Research
Bray Centre, Nathan Campus
Griffith University
170 Kessels Road
Nathan, QLD, 4111
Ethics committee country [2] 304233 0
Australia
Date submitted for ethics approval [2] 304233 0
02/06/2016
Approval date [2] 304233 0
03/06/2016
Ethics approval number [2] 304233 0
2016/410

Summary
Brief summary
The large number of patients require a central venous access device (CVAD) for the administration of intravenous fluids, medications, blood products and specialised treatments. These intravenous fluid lines will be accessed by nurses via a needleless connector (NC) multiple times every shift; however these connectors have also been linked with the development of CVAD associated bloodstream infection (CLABSI). The two most common causes of CLABSI are: the colonisation of the outer surface of the catheter during insertion from bacteria originating from the skin; and colonisation of the inner surface of the catheter through contamination of the hub or NC, often from poor non-touch technique practices from healthcare workers. These complications can be minimised, however while practice is variable, with little evidence to guide clinicians, research is required to reduce the gaps in this area.

The importance of decontaminating the needleless connectors (NC) has been highlighted prior to accessing the central venous access device (CVAD) by many of the current CVAD guidelines. However, the standard for the scrub time and the decontamination solution is still lacking, with some studies showing the time required for decontamination to be from 10 to 30 seconds using friction and 70% isopropyl alcohol swab. The Centre for Disease Control and Prevention (CDC) guidelines for the prevention of intravascular catheter-related infections suggest decontamination with a chlorhexidine/alcohol preparation. However, they do not mention a specific time for this procedure, other than stating that using a 70% alcohol solution for 3 to 5 seconds is not adequate (O'Grady, 2011). The national evidence based guidelines for preventing healthcare associated infections in National Health Service hospitals in England (Epic3) recommend disinfecting the connector for a minimum of 15 seconds with chlorhexidine gluconate in 70% isopropyl alcohol, then allowing it to dry prior to accessing the system. The Queensland Health I-Care Guideline for Tunnelled Central Venous Catheters recommends a 5 second scrub with a 70% alcohol solution and allowing the connector to dry before accessing the CVAD system. With each guideline having differing recommendations, clinicians may have difficulty deciding which method will reduce the risk of CLABSI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58634 0
Prof Claire Rickard
Address 58634 0
Level 2, Building 48
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 58634 0
Australia
Phone 58634 0
+61 7 36468725
Fax 58634 0
Email 58634 0
[email protected]
Contact person for public queries
Name 58635 0
Prof Claire Rickard
Address 58635 0
Level 2, Building 48
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 58635 0
Australia
Phone 58635 0
+61 7 36468725
Fax 58635 0
Email 58635 0
[email protected]
Contact person for scientific queries
Name 58636 0
Prof Claire Rickard
Address 58636 0
Level 2, Building 48
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 58636 0
Australia
Phone 58636 0
+61 7 36468725
Fax 58636 0
Email 58636 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No data will be shared to other parties other than investigators for this study


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
No additional documents have been identified.