Advanced Dressings for CVC Infection Prevention in PICU

University of Seville

Status: Enrolling

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

Treatments: Device: Conventional transparent polyurethane dressing; Device: 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated)

Study type: Interventional

Funder types: Other

Identifiers

NCT07175116

US-PICU-CV

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 2 months to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Experimental - Chlorhexidine gluconate-impregnated dressing

Experimental group

Description:

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

Treatment:

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

Control - Conventional transparent dressing

Active Comparator group

Description:

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

Treatment:

Device: Conventional transparent polyurethane dressing