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Biopatch (trademark) or Kendall (trademark) AMD Foam Disc to reduce the incidence of Central-Line-Associated Blood Stream Infection: A pilot randomized controlled trial

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000883516
Acronym
The CLABSI trial
Enrollment
100
Registered
2015-08-24
Start date
2016-02-01
Completion date
2016-07-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 whoeve

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.

Sponsors

Royal Brisbane and Womens Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

Current bloodstream infection Non-English speakers without interpreter Previous enrolment in the current study Known allergy to chlorhexidine or PHMB

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026