Chlorhexidine-impregnated transparent dressings to prevent central line infections in the PICU
Use of Advanced Fixation Dressings in Reducing Central Venous Catheter-related Bloodstream Infections in a Paediatric Intensive Care Unit
NA · University of Seville · NCT07175116
This trial will test whether chlorhexidine-impregnated transparent dressings reduce central line bloodstream infections in children in a pediatric intensive care unit.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 2 Months to 18 Years |
| Sex | All |
| Sponsor | University of Seville (other) |
| Locations | 1 site (Seville, Sevilla) |
| Trial ID | NCT07175116 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized, single-blind trial comparing chlorhexidine gluconate-impregnated transparent dressings (3M Tegaderm Antimicrobial) with standard transparent polyurethane dressings in children with central venous catheters admitted to a tertiary PICU. The study will track incidence of catheter-related bloodstream infection, catheter colonization, dressing-related skin complications, and the number of dressing changes. Eligible patients are PICU admissions with a newly placed central or peripherally inserted central venous catheter whose parent or guardian provides consent, excluding those with major immunodeficiency, severe neutropenia, or pre-existing MDR colonization. The trial is conducted at Hospital Universitario Virgen del Rocío in Seville, Spain.
Who should consider this trial
Good fit: Children admitted to the PICU who have a central or peripherally inserted central venous catheter and whose parent or legal guardian can give informed consent, and who do not have major immunodeficiency, neutropenia (<500/mm3), or pre-existing multidrug-resistant organism colonization.
Not a fit: Patients with known immunological disorders, severe neutropenia, or pre-existing colonization or infection with multidrug-resistant organisms are excluded and unlikely to benefit from this dressing comparison.
Why it matters
Potential benefit: If successful, the intervention could lower central line-associated bloodstream infections and related complications in PICU patients, reducing antibiotic use and length of stay.
How similar studies have performed: Prior studies, particularly in adults, have shown reduced catheter-related infections with chlorhexidine-impregnated dressings, while pediatric data are more limited but suggest potential benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seville, Sevilla
- Hospital Universitario Virgen del Rocío - Hospital Infantil — Seville, Sevilla, Spain (RECRUITING)
Study contacts
- Study coordinator: Manuel Pabón-Carrasco
- Email: mpabon2@us.es
- Phone: +34 669709548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Catheter-Related Infections, Central Venous Catheters, Bloodstream Infection, Pediatric Intensive Care Units