Ignite Creation Date:
2024-05-05 @ 11:28 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01346774
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2011-04-29
Brief Title:
Preventing Urinary Tract Infection Post-Surgery
Sponsor:
Betsy Foxman
Organization:
University of Michigan
Study Overview
Official Title:
Phase II Efficacy of Cranberry Powder in Preventing Catheter-associated Urinary Tract Infection Post Elective Gynecological Surgery
Status:
COMPLETED
Status Verified Date:
2015-05
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:
PUPS
Brief Summary:
Approximately 10-27 of patients undergoing gynecologic surgeries develop a catheter associated urinary tract infection CAUTI in the post operatory period as bladder catheterization is a common practice in gynecologic surgery Cranberry products provide alternative means for preventing CAUTI and could result in decreased use of antimicrobials In this pilot study we will enroll 200 women post gynecologic surgery and randomize them to take either cranberry powder capsules or placebo powder capsules The low risk of harm associated with using cranberry to reduce UTI coupled with its potential benefit makes it a desirable intervention for the prevention of CAUTI The conduct results of this pilot feasibility study will prepare us for the conduct of a large scale clinical trial
Detailed Description:
Cranberry products prevent bacteria that cause UTI especially Escherichia coli from adhering to bladder cell wall thus preventing infection Adherence of type 1 pili is inhibited by the fructose and of p pili by the proanthocyanidins present in cranberry
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HUM00041108 | OTHER | None | None |
| R21DK085290 | NIH | University of Michigan IRBMED | httpsreporternihgovquickSearchR21DK085290 |