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Trial registered on ANZCTR


Registration number
ACTRN12615000883516
Ethics application status
Approved
Date submitted
2/07/2015
Date registered
24/08/2015
Date last updated
5/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Biopatch (trademark) or Kendall (trademark) AMD Foam Disc to reduce the incidence of Central-Line-Associated Blood Stream Infection: A pilot randomized controlled trial
Scientific title
Among hospital patients requiring a central line is Biopatch (trademark) or Kendall (Trademark) AMD Foam Disc more effective in preventing central-line-associated blood stream infection? A randomized controlled trial
Secondary ID [1] 287036 0
None
Universal Trial Number (UTN)
U1111-1171-7823
Trial acronym
The CLABSI trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central catheter related blood stream infection 295501 0
Condition category
Condition code
Infection 296011 296011 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kendall 'Trademark' AMD Foam Disc ('Registered Trademark') is a foam disk containing 0.5% polyhexamethylene biguanide (PHMB), a broad spectrum antimicrobial that is effective up to 7-days (Covidien, Basingstoke, UK). The disc is administered as a dressing sponge which sits directly against the skin at the site of central line insertion. The disk is left in place for 7-days, unless there is a reason for removal or replacement (eg soiled dressing, treatment completed). The disk is placed by whoever inserts the catheter or by whoever changes the dressing. Adherence will be monitored by daily inspection of the site by a research nurse.
Intervention code [1] 292242 0
Prevention
Comparator / control treatment
Biopatch 'Trademark' (Ethicon Inc, Somerville, NJ, USA) is a chlorhexidine impregnated disc that is designed to release 2% chlorhexidine and inhibit bacterial and fungal growth for a number of days. The disc is administered as a dressing sponge which sits directly against the skin at the site of central line insertion. The disk is left in place for 7-days, unless there is a reason for removal or replacement (eg soiled dressing, treatment completed). The disk is placed by whoever inserts the catheter or by whoever changes the dressing. The disk is currently part of the standard dressing at the research hospital. Adherence to the study protocol will be monitored by daily inspection of the site by a research nurse.
Control group
Active

Outcomes
Primary outcome [1] 295471 0
Laboratory confirmed number of central line associated blood stream infections (CLABSI) per 10,000 line-days. Diagnosis will be made based on a presence of a bloodstream infection that is not secondary to an infection at another body site and where a central line has been in place for >2 days.
Timepoint [1] 295471 0
Daily monitoring for CLABSI from time of central line insertion until time of central line removal.
Secondary outcome [1] 315652 0
All cause blood stream infection defined as any positive blood culture that meets the Centers for Disease Control criteria for Laboratory Confirmed Bloodstream Infection (LCBSI)
Timepoint [1] 315652 0
Daily monitoring for infection from time of central line insertion until time of central line removal.
Secondary outcome [2] 315653 0
Cost effectiveness defined as direct costs to the hospital for the total episode of care, including costs of device and dressing replacement in addition to the costs of treating CVAD complications.
Timepoint [2] 315653 0
Assessed from time of central line insertion to time of hospital discharge.
Secondary outcome [3] 315654 0
Skin colonization rate assessed by microscopy evaluation from skin swab at insertion site.
Timepoint [3] 315654 0
On removal of the patch
Secondary outcome [4] 315655 0
Adverse events, such as skin rash, blisters, local or systemic reaction to either of the products.
Timepoint [4] 315655 0
Signs or symptoms of any adverse reactions will be assessed daily by the research nurse.
Secondary outcome [5] 315656 0
Patient satisfaction will be assessed by asking patients about the the products
Timepoint [5] 315656 0
On removal of the patch
Secondary outcome [6] 316580 0
Staff satisfaction will be assessed by interviewing staff about their experience of using the products
Timepoint [6] 316580 0
At the end of the study
Secondary outcome [7] 316581 0
Feasibility outcome 'Eligibility' assessed as at least 80 percent of patients screened will be eligible
Timepoint [7] 316581 0
This outcome will be assessed at the end of the recruitment period
Secondary outcome [8] 316582 0
Feasibility outcome 'Recruitment' assessed as at least 80 percent of eligible participants will enroll
Timepoint [8] 316582 0
This outcome will be assessed at the end of the recruitment period
Secondary outcome [9] 316583 0
Feasibility outcome 'treatment fidelity' assessed as at least 95 percent of patients will receive the correct dressing
Timepoint [9] 316583 0
This outcome will be assessed daily during routine site inspections by the research nurse
Secondary outcome [10] 316584 0
Feasibility outcome 'Retention' assessed as less than 5% of patients will be lost to follow up
Timepoint [10] 316584 0
This outcome will be assessed at the data collection period

Eligibility
Key inclusion criteria
Patients who are 16 years of age or older
Requiring a central catheter for at least three days
No previous central catheter this admission
Informed consent to participate
Central venous catheter inserted in Department of Medical Imaging, the Wattlebrae Day Therapy Unit or ICU
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current bloodstream infection
Non-English speakers without interpreter
Previous enrolment in the current study
Known allergy to chlorhexidine or PHMB

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)
Eligible, consenting patients will be allocated to their group using an automated allocation group generator which is built into a hand held device.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be via a centralised web-based service
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size for this pilot study will be based upon the requirements to assess feasibility. A sample of 50 per group will be sufficient to warrant extension to the larger trial if feasibility is established. Consequently, no statistical tests to assess differences between groups will be performed on pilot study data, and only descriptive data will be reported. Analysis will be performed using the intention-to-treat principle, meaning all patients will be analysed in the group to which they were assigned.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2015
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
13/07/2016
Date of last data collection
Anticipated
Actual
26/07/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3999 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 9918 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 291588 0
University
Name [1] 291588 0
Griffith University
Country [1] 291588 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Womens Hospital
Address
Butterfield Street
Herston 4006
QLD
Country
Australia
Secondary sponsor category [1] 290261 0
Individual
Name [1] 290261 0
Joan Webster
Address [1] 290261 0
Research & Development Unit
Level 2, Building 34
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
QLD 4006
Country [1] 290261 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293119 0
Royal Brisbane and Womens Hospital
Ethics committee address [1] 293119 0
Level 7 Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
QLD 4029
Ethics committee country [1] 293119 0
Australia
Date submitted for ethics approval [1] 293119 0
30/06/2015
Approval date [1] 293119 0
13/07/2015
Ethics approval number [1] 293119 0

Summary
Brief summary
A dressing containing chlorhexidine (Biopatch 'Trademark') has been introduced at the RBWH for all patients requiring a CVC. The dressing is expensive and the evidence for its effectiveness is contradictory. In related work we have some preliminary data showing that Biopatch may not be as effective as first thought in destroying potentially harmful bacteria. Another product, ‘Kendall 'Trademark' AMD Foam Disc’ has shown promise and we propose to compare the two antimicrobial dressings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58562 0
Prof Joan Webster
Address 58562 0
Research & Development Unit
Level 2, Bld 34
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
QLD 4006
Country 58562 0
Australia
Phone 58562 0
+61 7 3646 8590
Fax 58562 0
Email 58562 0
[email protected]
Contact person for public queries
Name 58563 0
Joan Webster
Address 58563 0
Research & Development Unit
Level 2, Bld 34
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
QLD 4006
Country 58563 0
Australia
Phone 58563 0
+61 7 3646 8590
Fax 58563 0
Email 58563 0
[email protected]
Contact person for scientific queries
Name 58564 0
Joan Webster
Address 58564 0
Research & Development Unit
Level 2, Bld 34
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
QLD 4006
Country 58564 0
Australia
Phone 58564 0
+61 7 3646 8590
Fax 58564 0
Email 58564 0
[email protected]

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