Advanced Dressings for CVC Infection Prevention in PICU

Not Applicable

Recruiting

• Conditions: Catheter-Related Infections; Pediatric Intensive Care Units; Central Venous Catheters; Bloodstream Infection

• Registration Number: NCT07175116
• Lead Sponsor: University of Seville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-05
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2025-11-15
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of central venous catheter-related bloodstream infection (CVC-BSI)	Baseline to 4 weeks or until catheter removal	CVC-BSI confirmed by clinical signs and positive blood culture according to Bacteriemia Zero protocol.

Secondary Outcome Measures

Name	Time	Method
Catheter colonisation rate	At catheter removal (up to 14 days after insertion)	Positive culture of catheter tip (\>15 CFU/mL) according to standard microbiological protocol.
Skin complications at insertion site	Up to 4 weeks	Erythema, pruritus or dermatitis at the catheter insertion site documented by clinical observation.
Number of dressing changes per patient	Up to 4 weeks	Total number of dressing replacements per patient recorded during catheterisation.

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocío - Hospital Infantil; 🇪🇸 Seville, Sevilla, Spain