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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07175116

Enrollment

250

Registered

2025-09-16

Start date

2024-05-01

Completion date

2025-11-25

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICE3M™ 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.

DEVICEConventional 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Masking description

This was a single-blind trial. The outcomes assessor was blinded to group allocation. Participants and care providers were aware of the dressing used

Eligibility

Sex/Gender

ALL

Age

2 Months to 18 Years

Healthy volunteers

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026