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CompletedNCT07001527Dressing RCTUpdated Jun 3, 2025

Dressing Impregnated With Chlorhexidine and Vancomycin for the Prophylaxis of Central Venous Catheter-related Infections - a Randomized Trial

A Phase 3 interventional study of Chlorhexidine and Chlorhexidine in Chlorhexidine, sponsored by Hospital Universitario Evangelico de Curitiba. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Hospital Universitario Evangelico de Curitiba · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Jun 2022, registered May 2025).
Phase
Phase 3
Study type
Interventional
Enrollment
516
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

You are being invited as a volunteer to participate in the study "Dressing impregnated with chlorhexidine and vancomycin for the prophylaxis of central venous catheter-related infections." The objective is to evaluate the incidence of bloodstream infection related to the catheter in ICU patients with central venous catheters (CVC), using dressings impregnated or not with chlorhexidine/vancomycin. We believe this study is important as it aims to evaluate a new dressing method intended to reduce bloodstream-related infections.

02

Conditions studied

  • Chlorhexidine

Keywords

  • chlorhexidine
03

In context

Catheter-Related Infections

107 studies on the registry are indexed under Catheter-Related Infections; 16 are open to participants now.

This study's enrollment of 516 is above the median of 150 across 76 interventional studies indexed under Catheter-Related Infections.

Browse Catheter-Related Infections studies →

Lead sponsor

Hospital Universitario Evangelico de Curitiba is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

IInclusion criteria included: age over 18 years, admitted to the ICU, need for a CVC placed in the ICU by the trained team, use of the CVC for a period exceeding 72 hours, and intact skin in the area of contact with the dressing. CVC inserted outside the ICU and need for two CVCs in the same patient simultaneously were exclusion criteria. A subsequent CVC could not be randomized. Other infections were not excluded during the evaluation. Only short-term CVC were evaluated (long-term and hemodialysis were excluded).

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
516 participants (actual)

Study arms

  • Active comparator
    Impregnated

    Impregnated

    Device: Chlorhexidine

  • Placebo comparator
    Control

    COmmon dressing

    Device: Chlorhexidine

Interventions

  • DeviceChlorhexidine

    dressing impregnated

    Also known as: Impregnated dressing

  • DeviceChlorhexidine

    COmmon dressing

    Also known as: COmmon dressing

06

What researchers measure

Primary outcomes

  1. Infection

    CRBSI was the primary endpoint

    Time frame: 30 days

07

Study locations

1 site
  • PUCPR
    Curitiba, PR 80050490, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07001527
Lead sponsor
Hospital Universitario Evangelico de Curitiba
Responsible party
Felipe Francisco Bondan Tuon (Professor, Pontifícia Universidade Católica do Paraná) — Principal investigator
First posted
Jun 3, 2025
Start date
Jun 1, 2022
Primary completion
Jun 2, 2022
Completion
Jun 1, 2023
Last update
Jun 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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