A Prospective Analysis of Biofilm in Urinary Catheters Study

Urinary Incontinence Clinical Trial

Official title:

A Prospective Anaylsis of Biofilm in Urinary Catheters Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987336
• Other study ID #: 56-RW-022
• Status: Completed
• Phase: N/A
• First received: March 4, 2013
• Last updated: December 10, 2015
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Southwest Regional Wound Care Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Urinary Incontinence

Locations

Country	Name	City	State
United States	Southwest Regional Wound Care Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Regional Wound Care Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Over a period of 20 weeks	No