NCT02658903

Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Oxys Medical AG · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.

Detailed description

This study is an open randomized controlled trial of 4 weeks duration. The intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. The catheter is used in patients which require longterm urinary catheterization over at least 1 month. The endpoint is bacteriological exam and the laboratory is blinded to the therapy status. Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. A colonization rate of \>95% is anticipated in the control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.

Conditions

• Urinary Infections

Interventions

Type	Name	Description
DEVICE	Oxys Catheter	The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.
DEVICE	Covidien Mona-Therm Foley catheter	The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-01-20
• Last updated: 2016-01-20

Locations

1 site across 1 country: Switzerland