Ignite Creation Date:
2024-05-05 @ 11:33 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01359046
Status:
COMPLETED
Last Update Posted:
2019-05-09
First Post:
2011-05-20
Brief Title:
Silver-impregnated Suprapubic Catheters SPC in Urogynecology
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 infectionsUTI 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None