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CompletedPhase 2Phase 3ACTRN12615000883516

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

Sponsor

Royal Brisbane and Womens Hospital

Enrollment

100 participants

Start Date

Feb 1, 2016

Study Type

Interventional

Conditions

Central catheter related blood stream infection

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.

Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Inclusion Criteria5

  • 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 Criteria4

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

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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, B

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.

Locations(1)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

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ACTRN12615000883516