NCT03868241

Coated Devices to Decrease Infection in the Intensive Care Unit

Randomized Controlled Open-label Trial Assessing the Efficacy of a Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-04-06
• Primary completion: 2020-02-13
• Completion: 2020-02-28
• First posted: 2019-03-11
• Last updated: 2020-03-09

Locations

6 sites across 1 country: Brazil