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Coated Devices to Decrease Infection in the Intensive Care Unit

NCT03868241 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2020-03-09

No results posted yet for this study

Summary

Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated (Bactiguard®) or habitual (non-coated) devices.

Conditions

  • Critically Ill

Interventions

DEVICE

Coated devices

Gold-silver-palladium coated devices (endotracheal tube, central venous catheter and urinary catheter) will be used whenever necessary. All three devices are required to be inserted as soon as possible after randomization and need for all three devices are the main inclusion criteria

DEVICE

Control

Devices without coating available at each participating intensive care unit

Sponsors & Collaborators

  • Bactiguard AB

    collaborator INDUSTRY

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Alexandre Biasi, MD/PhD · Hospital do Coração

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-06
Primary Completion
2020-02-13
Completion
2020-02-28

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03868241 on ClinicalTrials.gov