Use of Advanced Fixation Dressings in Reducing Central Venous Catheter-related Bloodstream Infections in a Paediatric Intensive Care Unit
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Seville
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Incidence of central venous catheter-related bloodstream infection (CVC-BSI)
Study Overview
Brief Summary
Randomised, single-blind clinical trial comparing chlorhexidine gluconate-impregnated transparent dressings versus conventional transparent dressings in the prevention of central venous catheter-related bloodstream infections (CVC-BSI) in paediatric patients admitted to a tertiary hospital PICU. Outcomes include incidence of BRCVC, catheter colonisation, dressing-related skin complications, and number of dressing changes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
This was a single-blind trial. The outcomes assessor was blinded to group allocation. Participants and care providers were aware of the dressing used
Eligibility Criteria
- Ages
- 2 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Admission to paediatric intensive care unit (PICU)
- •Central venous catheter placement (central or peripherally inserted)
- •Informed consent obtained from parent/legal guardian
Exclusion Criteria
- •Known immunological disorders
- •Neutropenia (<500/mm³)
- •Pre-existing colonisation or infection with multidrug-resistant organisms
Arms & Interventions
Experimental - Chlorhexidine gluconate-impregnated dressing
Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.
Intervention: 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated) (Device)
Control - Conventional transparent dressing
Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.
Intervention: Conventional transparent polyurethane dressing (Device)
Outcomes
Primary Outcomes
Incidence of central venous catheter-related bloodstream infection (CVC-BSI)
Time Frame: Baseline to 4 weeks or until catheter removal
CVC-BSI confirmed by clinical signs and positive blood culture according to Bacteriemia Zero protocol.
Secondary Outcomes
- Catheter colonisation rate(At catheter removal (up to 14 days after insertion))
- Skin complications at insertion site(Up to 4 weeks)
- Number of dressing changes per patient(Up to 4 weeks)
Investigators
MANUEL PABON CARRASCO
Principal Investigator, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville
University of Seville