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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000883516
• Date of registration: 24/08/2015
• Prospective Registration: Yes
• Primary sponsor: Royal Brisbane and Womens Hospital
• 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
• Date of first enrolment: 01/02/2016
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000883516.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 2 / Phase 3

Countries of recruitment

Australia

Contacts

• Name: Prof Joan Webster

• Name: Prof Joan Webster

Key inclusion & exclusion criteria

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


Age minimum: 16 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Studies of infection and infectious agents

Central catheter related blood stream infection;
Central catheter related blood stream infection

Intervention(s)

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.

Primary Outcome(s)

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. [Daily monitoring for CLABSI from time of central line insertion until time of central line removal.]

Secondary Outcome(s)

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.
[Assessed from time of central line insertion to time of hospital discharge.]

Feasibility outcome 'Retention' assessed as less than 5% of patients will be lost to follow up[This outcome will be assessed at the data collection period]

Patient satisfaction will be assessed by asking patients about the the products[On removal of the patch]

Adverse events, such as skin rash, blisters, local or systemic reaction to either of the products. [Signs or symptoms of any adverse reactions will be assessed daily by the research nurse.]

Skin colonization rate assessed by microscopy evaluation from skin swab at insertion site.[On removal of the patch]

Staff satisfaction will be assessed by interviewing staff about their experience of using the products[At the end of the study]

Feasibility outcome 'Recruitment' assessed as at least 80 percent of eligible participants will enroll[This outcome will be assessed at the end of the recruitment period]

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)[Daily monitoring for infection from time of central line insertion until time of central line removal.]

Feasibility outcome 'Eligibility' assessed as at least 80 percent of patients screened will be eligible[This outcome will be assessed at the end of the recruitment period]

Feasibility outcome 'treatment fidelity' assessed as at least 95 percent of patients will receive the correct dressing[This outcome will be assessed daily during routine site inspections by the research nurse]

Secondary ID(s)

None

Source(s) of Monetary Support

Griffith University

Secondary Sponsor(s)

Joan Webster

Ethics review

Status: Approved
Approval date:
Contact:

Royal Brisbane and Womens Hospital