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OpenTrials
Completed

NCT Number: NCT07175116

Advanced Dressings for CVC Infection Prevention in PICU

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.

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Key information

Conditions

Catheter-Related Infections Bloodstream Infection Central Venous Catheters Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Intensive Care Units Sepsis Systemic Inflammatory Response Syndrome

Age range

2 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen del Rocío - Hospital Infantil

Seville, Sevilla, 41004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With Central Venous Catheter-Related Bloodstream Infection (CVC-BSI)

    Time frame: From catheter insertion to 4 weeks or until catheter removal

    Participants who developed central venous catheter-related bloodstream infection (CVC-BSI), confirmed according to the Bacteriemia Zero protocol based on clinical signs and positive blood culture findings during follow-up.

Secondary outcomes

  1. Catheter Colonisation Rate

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

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

  2. Skin Complications at Insertion Site

    Time frame: Up to 4 weeks

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

  3. Number of Dressing Changes Per Patient

    Time frame: Up to 4 weeks

    Total number of dressing replacements per patient recorded during catheterisation.

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Collaborators

  • Hospitales Universitarios Virgen del Rocío

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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