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

H

Hospital Universitario Evangelico de Curitiba

Status and phase

Completed
Phase 3

Conditions

Chlorhexidine

Treatments

Device: Chlorhexidine

Study type

Interventional

Funder types

Other

Identifiers

NCT07001527
PUCPR-Dressing
0001

Details and patient eligibility

About

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.

Enrollment

516 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

516 participants in 2 patient groups, including a placebo group

Impregnated
Active Comparator group
Description:
Impregnated
Treatment:
Device: Chlorhexidine
Device: Chlorhexidine
Control
Placebo Comparator group
Description:
COmmon dressing
Treatment:
Device: Chlorhexidine
Device: Chlorhexidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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