Catheter-Related InfectionsNCT07175116
Advanced Dressings for CVC Infection Prevention in PICU
A study testing 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated) and Conventional transparent polyurethane dressing in people with Catheter-Related Infections and Central Venous Catheters, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Catheter-Related Infections, Central Venous Catheters, Bloodstream Infection
- What is being tested?
- 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated) and Conventional transparent polyurethane dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2024to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Admission to paediatric intensive care unit (PICU)
- Central venous catheter placement (central or peripherally inserted)
- Informed consent obtained from parent/legal guardian
Who cannot join
- Known immunological disorders
- Neutropenia (<500/mm³)
- Pre-existing colonisation or infection with multidrug-resistant organisms
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Virgen del Rocío - Hospital Infantil
Seville, Sevilla, 41004
About this study
Official title: Use of Advanced Fixation Dressings in Reducing Central Venous Catheter-related Bloodstream Infections in a Paediatric Intensive Care Unit
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.
- Conditions
- Catheter-Related Infections, Central Venous Catheters, Bloodstream Infection, Pediatric Intensive Care Units
- Being tested
- 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated), Conventional transparent polyurethane dressing
- Medical subject headings
- Catheter-Related Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated)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.
Conventional transparent polyurethane dressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Chlorhexidine gluconate-impregnated dressing | Experimental | Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site. Receives: Device: 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated) |
| Control - Conventional transparent dressing | Active comparator | Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site. Receives: Device: Conventional transparent polyurethane dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Central Venous Catheter-Related Bloodstream Infection (CVC-BSI)
Participants who developed central venous catheter-related bloodstream infection (CVC-BSI), confirmed according to the Bacteriemia Zero protocol based on clinical signs and positive blood culture findings during follow-up.
Measured: From catheter insertion to 4 weeks or until catheter removal
Secondary outcomes (3)
Catheter Colonisation Rate
Positive culture of catheter tip (>15 CFU/mL) according to standard microbiological protocol.
Measured: At catheter removal (up to 14 days after insertion)
Skin Complications at Insertion Site
Erythema, pruritus or dermatitis at the catheter insertion site documented by clinical observation.
Measured: Up to 4 weeks
Number of Dressing Changes Per Patient
Total number of dressing replacements per patient recorded during catheterisation.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 May 2024
- Primary completion15 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Responsible party
- Principal investigator, MANUEL PABON CARRASCO, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175116
- Sponsor's protocol ID
- US-PICU-CV
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2025
- Last updated
- 13 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Portero-Prados FJ, Pabon-Carrasco M, Ponce-Blandon JA. Effectiveness of chlorhexidine gluconate-impregnated dressings in preventing central line-associated bloodstream infection in a paediatric intensive care unit: A randomised controlled trial. Intensive Crit Care Nurs. 2026 Oct;96:104441. doi: 10.1016/j.iccn.2026.104441. Epub 2026 May 7.
PubMed 42102647
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Advanced Fixation Dressings in Reducing Central Venous Catheter-related Bloodstream Infections in a Paediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07175116
- Acronym / sponsor ID
- US-PICU-CV
- Conditions
- Catheter-Related Infections, Central Venous Catheters, Bloodstream Infection, Pediatric Intensive Care Units
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Posted 13 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - Chlorhexidine gluconate-impregnated dressing | Experimental | Device: 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated)Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site. |
| Control - Conventional transparent dressing | Active comparator | Device: Conventional transparent polyurethane dressingParticipants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Admission to paediatric intensive care unit (PICU)
- Central venous catheter placement (central or peripherally inserted)
- Informed consent obtained from parent/legal guardian
Key exclusion criteria (3 listed)
- Known immunological disorders
- Neutropenia (<500/mm³)
- Pre-existing colonisation or infection with multidrug-resistant organisms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental - Chlorhexidine gluconate-impregnated dressing |
| Conventional transparent polyurethane dressingTransparent 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. | Device | Control - Conventional transparent dressing |
Primary outcome
Number of Participants With Central Venous Catheter-Related Bloodstream Infection (CVC-BSI)
Time frame: From catheter insertion to 4 weeks or until catheter removal
Participants who developed central venous catheter-related bloodstream infection (CVC-BSI), confirmed according to the Bacteriemia Zero protocol based on clinical signs and positive blood culture findings during follow-up.
3 secondary outcomes
Catheter Colonisation Rate
Time frame: At catheter removal (up to 14 days after insertion)
Skin Complications at Insertion Site
Time frame: Up to 4 weeks
Number of Dressing Changes Per Patient
Time frame: Up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42102647Portero-Prados FJ, Pabon-Carrasco M, Ponce-Blandon JA. Effectiveness of chlorhexidine gluconate-impregnated dressings in preventing central line-associated bloodstream infection in a paediatric intensive care unit: A randomised controlled trial. Intensive Crit Care Nurs. 2026 Oct;96:104441. doi: 10.1016/j.iccn.2026.104441. Epub 2026 May 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated) and Conventional transparent polyurethane dressing in people with Catheter-Related Infections and Central Venous Catheters, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Central Venous Catheter-Related Bloodstream Infection (CVC-BSI) (time frame: From catheter insertion to 4 weeks or until catheter removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07175116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.