RecruitingNot ApplicableNCT07175116

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


Sponsor

University of Seville

Enrollment

250 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 MonthsMax Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria3

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

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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.


Locations(1)

Hospital Universitario Virgen del Rocío - Hospital Infantil

Seville, Sevilla, Spain

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NCT07175116


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