A Prospective Anaylsis of Biofilm in Urinary Catheters Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter.
Study Overview
Brief Summary
To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter. A 30cc urine sample would also be collected from the same subject, and analyzed.
Detailed Description
After obtaining informed consent, concurrent with the changing of the Foley catheter in the clinic, would be obtaining a 30 cc. sample of urine which would also be fast frozen and stored in a -81 degree freezer until shipped to the Venter clinic on dry ice.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject must be 18 years of age.
- •Subject is attending weekly office visits at SW Wound Care Center as an out- patient.
- •Subject must have an indwelling Foley catheter.
- •Subject is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment.
- •Subject is willing and able to comply with all specified care and visit requirements.
Exclusion Criteria
- •Subject refuses to participate in the study.
- •Subject is expected to be non-compliant.
- •Subject is a resident in a nursing home, or institutionalized.
- •Subject is pregnant.
- •Subject has a Legally Authorized Representative
Outcomes
Primary Outcomes
To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter.
Time Frame: Over a period of 20 weeks
the proteomics, metabolomics and metagenomics ("omics") data will be analyzed and integrated in order to understand the microbial population dynamics and the interactions with the human subject host responses which may include antibacterial defenses, local inflammation, immune tolerance towards bacteria
Secondary Outcomes
No secondary outcomes reported