Advanced Dressings for CVC Infection Prevention in PICU

Use of Advanced Fixation Dressings in Reducing Central Venous Catheter-related Bloodstream Infections in a Paediatric Intensive Care Unit

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 Overview

• Status: Recruiting
• Conditions: Catheter-Related Infections; Bloodstream Infection; Central Venous Catheters; Pediatric Intensive Care Units
• Intervention / Treatment: Device: 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated); Device: Conventional transparent polyurethane dressing

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Pabón-Carrasco; Phone Number: +34 669709548; Email: mpabon2@us.es

Study Locations

• Spain
  • Sevilla
    • Seville, Sevilla, Spain, 41004
      • Recruiting
      • Hospital Universitario Virgen del Rocío - Hospital Infantil
      • Contact: Manuel Pabón-Carrasco; Email: mpabon2@us.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental - Chlorhexidine gluconate-impregnated dressing; Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.	Device: 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated); 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.
Active Comparator: Control - Conventional transparent dressing; Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.	Device: Conventional transparent polyurethane dressing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 4 weeks or until catheter removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter colonisation rate	Positive culture of catheter tip (>15 CFU/mL) according to standard microbiological protocol.	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.	Up to 4 weeks
Number of dressing changes per patient	Total number of dressing replacements per patient recorded during catheterisation.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: University of Seville
• Collaborators: Hospitales Universitarios Virgen del Rocío

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): November 15, 2025

Study Registration Dates

• First Submitted: September 5, 2025
• First Submitted That Met QC Criteria: September 11, 2025
• First Posted (Estimated): September 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Catheter-Related Infections
• Other Study ID Numbers: US-PICU-CV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No