NCT01681511

A Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter for Reduction of CAUTI.

A Randomized Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter Attached to an Antimicrobial Anti-Reflux Device for Reduction of Catheter-Associated Urinary Tract Infection

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Innovative Chemical and Environmental Technologies, Inc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this pilot study is to demonstrate the feasibility of recruiting eligible patients for the purposes of assessing the temporal aspects and rates of Catheter Associated Urinary Tract Infection (CAUTI), based on the agreed-upon case definition so that the numbers needed for a pivotal study can be better estimated.

Detailed description

This pilot study will be a prospective, single site, randomized clinical investigation comparing the safety and effectiveness of the ICET TIC antimicrobial Foley catheter, against the infection control standard-of-care, the BARD ® LUBRI-SIL® I.C. Foley catheter. Approximately 160 patients will be screened. The study has been designed to enroll approximately 120 eligible subjects to obtain about 60 evaluable subjects (30 in each arm). Subjects who meet the eligibility criteria will be enrolled into the study and randomly assigned to the experimental or standard-of-care group in a 1:1 ratio.

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
DEVICE	ICET™ TIC Foley Catheter	The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
DEVICE	BARD® LUBRI-SIL® IC Foley Catheter	The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-09-10
• Last updated: 2014-04-28
• Results posted: 2014-04-10

Locations

1 site across 1 country: United States