A Prospective Analysis of Biofilm in Urinary Catheters Study

N/ACompletedNCT01987336

Southwest Regional Wound Care Center9 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Urinary Incontinence

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject must be 18 years of age. 2. Subject is attending weekly office visits at SW Wound Care Center as an out- patient. 3. Subject must have an indwelling Foley catheter. 4. Subject is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment. 5. Subject is willing and able to comply with all specified care and visit requirements. Exclusion Criteria: 1\. Subject refuses to participate in the study. 2. Subject is expected to be non-compliant. 3. Subject is a resident in a nursing home, or institutionalized. 4. Subject is pregnant. 5. Subject has a Legally Authorized Representative \-

Locations (1)

Southwest Regional Wound Care Center

Lubbock, Texas, United States

Outcomes

Primary Outcomes

To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter.

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

Time frame: Over a period of 20 weeks

Data from ClinicalTrials.gov

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