Advanced Dressings for CVC Infection Prevention in PICU

NCT ID: NCT07175116

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Catheter-Related Infections Central Venous Catheters Bloodstream Infection Pediatric Intensive Care Units

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
This was a single-blind trial. The outcomes assessor was blinded to group allocation. Participants and care providers were aware of the dressing used

Study Groups

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Experimental - Chlorhexidine gluconate-impregnated dressing

Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.

Group Type EXPERIMENTAL

3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated)

Intervention Type DEVICE

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.

Control - Conventional transparent dressing

Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.

Group Type ACTIVE_COMPARATOR

Conventional transparent polyurethane dressing

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role collaborator

University of Seville

OTHER

Sponsor Role lead

Responsible Party

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MANUEL PABON CARRASCO

Principal Investigator, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Virgen del Rocío - Hospital Infantil

Seville, Sevilla, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Manuel Pabón-Carrasco

Role: CONTACT

+34 669709548

Facility Contacts

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Manuel Pabón-Carrasco

Role: primary

Other Identifiers

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US-PICU-CV

Identifier Type: -

Identifier Source: org_study_id

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