Dressing Impregnated With Chlorhexidine and Vancomycin for the Prophylaxis of Central Venous Catheter-related Infections - a Randomized Trial
Dressing RCT
2 other identifiers
interventional
516
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2022
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 3, 2025
CompletedJune 3, 2025
May 1, 2025
1 day
May 23, 2025
May 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infection
CRBSI was the primary endpoint
30 days
Study Arms (2)
Impregnated
ACTIVE COMPARATORImpregnated
Control
PLACEBO COMPARATORCOmmon dressing
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PUCPR
Curitiba, Paraná, 80050490, Brazil
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 23, 2025
First Posted
June 3, 2025
Study Start
June 1, 2022
Primary Completion
June 2, 2022
Study Completion
June 1, 2023
Last Updated
June 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share