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Trial registered on ANZCTR


Registration number
ACTRN12619001448134
Ethics application status
Approved
Date submitted
15/09/2019
Date registered
18/10/2019
Date last updated
18/10/2019
Date data sharing statement initially provided
18/10/2019
Date results provided
18/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intervention to ascertain the most effective disinfection agent, and time to clean intravenous access port in adult patients
Scientific title
Effectiveness of decontamination of Smartsite needleless connectors with 70% Alcohol or 2% chlorhexidine in 70% alcohol timed at 5, 10 or 15 seconds in the clinical environment, a factorial randomized control trial in adult medical patients
Secondary ID [1] 299237 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection 314369 0
Condition category
Condition code
Infection 312703 312703 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Factorial study. Needleless connectors were disinfected with 70% isopropyl alcohol, 5 10 and 15 seconds or 2% chlorhexidine in 70% isopropyl alcohol for 5, 10 or 15 seconds.
Participants gave verbal consent for their needleless connectors to be swabbed (pre-decontamination of the needleless connector). The needleless connector was then swabbed by the researcher for a specific period of time with a designated antiseptic agent (as per randomisation service). After disinfection of the needleless connector it was again swabbed and the swab sent to the microbiology lab to ascertain any micro-organism growth. A comparison of growth before and after decontamination determined success of the intervention.
Needleless connectors were swabbed with either 70% isopropyl alcohol prep pads (for professional and hospital use) - prepackaged, or 70% isopropyl alcohol with 2 % chlorhexidine (also prepacked). Prep pads were sterile. The needleless connectors were manually cleaned by the researcher (after cleaning hands) for 5, 10 or 15 seconds (as per randomisation).
Each needleless connector was only used once in the study, and pre and post swab was undertaken for all 300 randomised needleless connectors.
The intervention was carried out by a Registered Nurse (part of the research team)
Adherence to the protocol (with strict instructions on how to decontaminate the needleless connector) was adhered to by the research nurse, practice was observed by another Registered Nurse (also part of the research) team. Analysis of swabs was undertaken by the Microbiologist. A data collection sheet was completed for each of the 300 needleless connectors.

There were six arms to the trial (decontamination). Isopropyl alcohol 70% for 5 seconds, Isopropyl alcohol 70% for 10 seconds, Isopropyl alcohol 70% for 15 seconds, Isopropyl alcohol (70%) with 2% chlorhexidine 5 seconds, Isopropyl alcohol (70%) with 2% chlorhexidine for 10 seconds, and Isopropyl alcohol (70%) with 2% chlorhexidine for 15 seconds
Intervention code [1] 315532 0
Prevention
Comparator / control treatment
comparison of 70% Isopropyl alcohol and 2% chlorhexidine (CHG) in 70% isopropyl alcohol, at times of 5, 10 and 15 seconds. The comparator is 70% isopropyl alcohol at 15 seconds.
Control group
Active

Outcomes
Primary outcome [1] 321345 0
The number of micro-organisms present on the needleless connectors after disinfection by standardised swab, sent to the micro-biology lab for analysis by scientist
Timepoint [1] 321345 0
Sample taken 30 seconds after the randomised disinfection. Disinfection solution (70% alcohol or 2% chlorhexidine in 70% alcohol), needleless connectors scrubbed for at 5, 10 and 15 seconds.
Secondary outcome [1] 374707 0
Nil
Timepoint [1] 374707 0
Nil

Eligibility
Key inclusion criteria
Peripheral intravenous catheter insitu for >24 hours
Peripheral intravenous catheter free on a infusion
Patient consent
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to consent
Allergy to chlorhexidine

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)
Griffith University Independent Web-based Randomisation Service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer web based service
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Micro-organism analysis undertaken by micro-biology laboratory (Clinical Micro-biologist). Identification of organism by VITEK MS MALDITOF (Biomerieux, Marcy-I'Etoite, France). Data imported into STATA. The outcome (micro-organism growth) set up as a dichotomous variable (yes or no), exposures were either categorical or ordinal variables. The null hypothesis of no difference in growth between the various exposure was assessed with the Fisher exact test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2017
Date of last participant enrolment
Anticipated
Actual
21/12/2018
Date of last data collection
Anticipated
Actual
21/12/2018
Sample size
Target
300
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14760 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 27992 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 303777 0
Hospital
Name [1] 303777 0
Princess Alexandra Hospital
Country [1] 303777 0
Australia
Primary sponsor type
Individual
Name
Karen Slater
Address
Karen Slater
Princess Alexandra Hospital
199 Ipswich Rd,
Woolloongabba 4102
Country
Australia
Secondary sponsor category [1] 304125 0
None
Name [1] 304125 0
Address [1] 304125 0
Country [1] 304125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304297 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 304297 0
Ethics committee country [1] 304297 0
Australia
Date submitted for ethics approval [1] 304297 0
21/07/2017
Approval date [1] 304297 0
12/09/2017
Ethics approval number [1] 304297 0
HREC/17/QPAH/517

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

Contacts
Principal investigator
Name 96438 0
Ms Karen Slater
Address 96438 0
Princess Alexandra Hospital,
199 Ipswich Rd,
Woolloongabba, 4102.
Brisbane,
Queensland
Country 96438 0
Australia
Phone 96438 0
+61 07 3176 7100
Fax 96438 0
Email 96438 0
karen.slater@health.qld.gov.au
Contact person for public queries
Name 96439 0
Karen Slater
Address 96439 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba 4102
Brisbane,
Queensland
Country 96439 0
Australia
Phone 96439 0
+61 07 3176 7100
Fax 96439 0
Email 96439 0
karen.slater@health.qld.gov.au
Contact person for scientific queries
Name 96440 0
Karen Slater
Address 96440 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba 4102
Brisbane,
Queensland
Country 96440 0
Australia
Phone 96440 0
+61 07 3176 7100
Fax 96440 0
Email 96440 0
karen.slater@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.