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Advanced Dressings for CVC Infection Prevention in PICU

ConditionsCatheter-Related InfectionsCentral Venous CathetersBloodstream InfectionPediatric Intensive Care Units
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorUniversity of Seville

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admission to paediatric intensive care unit (PICU)

Central venous catheter placement (central or peripherally inserted)

Informed consent obtained from parent/legal guardian

Disqualifiers

Known immunological disorders

Neutropenia (<500/mm³)

Pre-existing colonisation or infection with multidrug-resistant organisms

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated)

    Device

    Individually applied transparent dressing containing chlorhexidine gluconate (0.5-1 mg/cm²) for antimicrobial protection at the central venous catheter insertion site. The dressing maintains site visibility, reduces catheter manipulation frequency, and provides sustained release of chlorhexidine to lower colonisation and bloodstream infection risk.

  • Conventional transparent polyurethane dressing

    Device

    Transparent polyurethane dressing without antimicrobial impregnation, applied at the central venous catheter insertion site. This dressing allows site inspection and is widely used in standard paediatric intensive care protocols but provides no antimicrobial activity.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Experimental - Chlorhexidine gluconate-impregnated dressingExperimental treatment 1 intervention
Group B: Control - Conventional transparent dressingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of central venous catheter-related bloodstream infection (CVC-BSI)

CVC-BSI confirmed by clinical signs and positive blood culture according to Bacteriemia Zero protocol.

Time frame
Baseline to 4 weeks or until catheter removal

Secondary outcomes

1

Catheter colonisation rate

Positive culture of catheter tip (\>15 CFU/mL) according to standard microbiological protocol.

Time frame
At catheter removal (up to 14 days after insertion)
2

Skin complications at insertion site

Erythema, pruritus or dermatitis at the catheter insertion site documented by clinical observation.

Time frame
Up to 4 weeks
3

Number of dressing changes per patient

Total number of dressing replacements per patient recorded during catheterisation.

Time frame
Up to 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Seville

Lead sponsor

Hospitales Universitarios Virgen del Rocío

Collaborator

Source ClinicalTrials.gov
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