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Advanced Dressings for CVC Infection Prevention in PICU

NCT07175116 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-09-16

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Hospitales Universitarios Virgen del Rocío

    collaborator OTHER

  • University of Seville

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-11-15
Completion
2025-11-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07175116 on ClinicalTrials.gov