Advanced Dressings for CVC Infection Prevention in PICU

NCT07175116 | Recruiting DMC

• 1 other identifier: US-PICU-CV
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  Baseline to 4 weeks or until catheter removal

Secondary Outcomes (3)

• 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

Study Arms (2)

Experimental - Chlorhexidine gluconate-impregnated dressing

EXPERIMENTAL

Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.

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

Control - Conventional transparent dressing

ACTIVE COMPARATOR

Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.

Device: Conventional transparent polyurethane dressing

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.

Experimental - Chlorhexidine gluconate-impregnated dressing

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.

Control - Conventional transparent dressing

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Admission to paediatric intensive care unit (PICU)
• Central venous catheter placement (central or peripherally inserted)
• Informed consent obtained from parent/legal guardian

You may not qualify if:

• Known immunological disorders
• Neutropenia (\<500/mm³)
• Pre-existing colonisation or infection with multidrug-resistant organisms

Sponsors & Collaborators

• University of Seville: lead
• Hospitales Universitarios Virgen del Rocío: collaborator

Study Sites (1)

Hospital Universitario Virgen del Rocío - Hospital Infantil

Seville, Sevilla, 41004, Spain

RECRUITING

MeSH Terms

Conditions

Catheter-Related Infections; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Manuel Pabón-Carrasco

CONTACT

+34 669709548; mpabon2@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This was a single-blind trial. The outcomes assessor was blinded to group allocation. Participants and care providers were aware of the dressing used
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 16, 2025
• Study Start: May 1, 2024
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

ES (1)