Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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