Actively Recruiting

Phase Not Applicable
Age: 2Months - 18Years
All Genders
ID07175116

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

Led by University of Seville · Updated on 2025-09-16

250

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Seville

Lead Sponsor

H

Hospitales Universitarios Virgen del Rocío

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two types of transparent dressings used on central venous catheters (CVCs) to prevent bloodstream infections in children admitted to a pediatric intensive care unit (PICU). This randomized, single-blind trial compares dressings impregnated with chlorhexidine gluconate to conventional transparent dressings. The study aims to understand which dressing better reduces catheter-related infections, catheter colonization, skin complications, and the frequency of dressing changes. Participants will be randomly assigned to receive either the advanced chlorhexidine gluconate-impregnated transparent dressing or the standard transparent polyurethane dressing without antimicrobial properties at the catheter insertion site. The chlorhexidine dressing provides sustained antimicrobial protection while allowing visibility of the site and may reduce the need for frequent catheter manipulation. Both dressings are applied at the central venous catheter insertion area and monitored during the study period. During the study, participants will be observed from baseline up to four weeks or until catheter removal, whichever occurs first. Researchers will track infection rates, catheter colonization at removal (up to 14 days after insertion), skin issues at the insertion site, and how often dressings need changing. The study involves careful monitoring of the catheter site and overall health while participating, with safety and infection outcomes recorded throughout the follow-up period.

CONDITIONS

Brief Title

Advanced Dressings for CVC Infection Prevention in PICU

Who Can Participate

Age: 2Months - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admission to paediatric intensive care unit (PICU)
  • Central venous catheter placement (central or peripherally inserted)
  • Informed consent obtained from parent/legal guardian
  • Age between 2 months and 18 years
Not Eligible

You will not qualify if you...

  • Known immunological disorders
  • Neutropenia (neutrophil count less than 500/mm³)
  • Pre-existing colonisation or infection with multidrug-resistant organisms

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Up to 4 weeks or until catheter removal

Participants receive either advanced transparent dressings impregnated with chlorhexidine gluconate or standard transparent polyurethane dressings at the central venous catheter insertion site.

Dressing changes as needed during catheter placement

Trial Site Locations

Total: 1 location

1

Hospital Universitario Virgen del Rocío - Hospital Infantil

Seville, Sevilla, Spain, 41004

Actively Recruiting

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Research Team

M

Manuel Pabón-Carrasco

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Effectiveness of chlorhexidine gluconate-impregnated dressings in preventing central line-associated bloodstream infection in a paediatric intensive care unit: A randomised controlled trial.

Francisco Javier Portero-Prados, Manuel Pabón-Carrasco, José Antonio Ponce-Blandón

https://pubmed.ncbi.nlm.nih.gov/42102647