NCT01359046

Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare urinary tract infection rates among women undergoing urogynecological procedures with a silver-alloy suprapubic catheter compared to the standard suprapubic catheter.

Detailed description

Urinary catheters are used routinely in the postoperative care of urogynecology patients after surgery involving the genitourinary tract. However, Urinary tract infections(UTI) associated with indwelling catheter is the second leading cause of nosocomial infections. 20% of hospital acquired bacteremia arise from UTI with an associated mortality of 10%. There are many different types of catheters available for use. Standard indwelling catheters are made from a variety of materials including polyvinyl chlorine, plastic, plain latex, polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer. Specialized catheters have been developed with the aim of reducing infection. Strategies generally involved coating the inner, outer or both surfaces of the catheter with antimicrobial materials. These materials can be antibiotic or antiseptic with the most common antiseptic material used being silver. Silver ions are bactericidal, are used safely when applied topically to humans and used in controlling infections. Previous studies comparing UTI rates in transurethral catheters have reported a significant reduction of UTI rate in silver-alloy catheters with a range of 5-12% compared to standard catheters with a range of 7-50%. There are no studies comparing the UTI rate in silver-alloy supra-pubic catheters to standard supra-pubic catheters. The investigators hypothesize that this study will show a statistically significant decrease in UTI rate among the individuals with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.

Conditions

• Infection Associated With Catheter
• Urinary Tract Infection

Interventions

Type	Name	Description
DEVICE	silver SPC	subject randomized to receive silver alloy impregnated catheter
DEVICE	standard SPC	subject randomized to receive standard catheter

Timeline

• Start date: 2011-07-01
• Primary completion: 2018-03-02
• Completion: 2018-03-09
• First posted: 2011-05-24
• Last updated: 2019-05-09
• Results posted: 2019-04-26

Locations

1 site across 1 country: United States