None listed
Conditions
Brief summary
Central venous catheters (CVCs) are used in most intensive care units (ICU) patients to deliver intravenous treatment and monitor central venous pressures. Whilst integral to patient treatment, CVCs are associated with significant risk, the most serious being infection. Polyhecamethylene buguanide (PHMB)-impregnated foam discs around the CVC insertion site may work to reduce the incidence of CVC infection, but have so far not been tested in a critical care environment. The aim of this pilot study is to assess feasibility of study protocol and processes to inform budget, sample size calculations and protocol development of a larger, definitive trial. The outcome measures for this pilot study are feasibility (eligibility, recruitment, retention, protocol fidelity, missing data, patient/staff satisfaction), central line-associated bloodstream infection (CLABSI), other BSIs, venous/arterial infection, skin complications, device/dressing functional dwell time, SAEs and cost-effectiveness.
Interventions
Foam stabilising dressing (ConvaTec EASI-V) and polyurethane dressing (Smith and Nephew IV3000) + Kendall AMD Antimicrobial Foam Disc.
The study and related interventions will be actively implemented whilst the patient has a central venous catheter (CVC) in situ. This will encompass both their time in the intensive care unit, as well as the ward after the patient's ICU discharge. As such, the duration of observation will cease when the CVC is removed (usually no longer than 7 days).
CVCs will b
Foam stabilising dressing (ConvaTec EASI-V) and polyurethane dressing (Smith and Nephew IV3000) + Kendall AMD Antimicrobial Foam Disc. The study and related interventions will be actively implemented whilst the patient has a central venous catheter (CVC) in situ. This will encompass both their time in the intensive care unit, as well as the ward after the patient's ICU discharge. As such, the duration of observation will cease when the CVC is removed (usually no longer than 7 days). CVCs will be inserted by an appropriately trained inserter as per hospital policy. The study dressings will be applied by clinical staff at time of CVC insertion. Clinical staff will be responsible for the care and maintenance of the CVC as per hospital policy; including dressing changes which will occur every 7 days, or more frequently if clinically indicated due to being soiled, loose or moist. A member of the research team will supply the relevant dressings to bedside clinical staff and extensive education will be given to clinical staff on how to apply, care for and remove the dressings. CVC removal will be at the discretion of the treating team, using usual hospital criteria. CVCs will be visually assessed every day to assess for patient skin complications. Patients and staff will also be asked to rate their satisfaction with the intervention dressing of the CVC. Additionally, any protocol violations will be recorded.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Greater than or equal to 18 years old. (2) Requires a CVC for greater than or equal to 72 hours (3) Informed, written consent
Exclusion criteria
(1) Current bloodstream infection (laboratory confirmed within 48 hours of screening) (2) Concurrent CVC present or anticipated for > 24 hours (3) Non-English speaking without an interpreter (4) Previous study enrolment (5) Known CHG or PHMB allergy (6) Pre-existing dermatitis/rash/burns at insertion site
Outcome results
None listed