Advanced Dressings for CVC Infection Prevention in PICU

University of Seville250 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

250

Conditions

Interventions

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 dressingDEVICE

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.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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)

Skin complications at insertion site

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

Time frame: Up to 4 weeks

Number of dressing changes per patient

Total number of dressing replacements per patient recorded during catheterisation.