A Prospective Analysis of Biofilm in Urinary Catheters Study

NCT01987336 | Completed

• 1 other identifier: 56-RW-022
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Standard Foley Catheter

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who require a standard foley catheter.

You may qualify if:

• 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Southwest Regional Wound Care Center: lead

Study Sites (1)

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A 30cc urine sample would also be collected, along with the used catheter. The molecular evaluation will be looking specifically at the biofilm accumulated on the catheter surface. The technologies to be used are proteomics, metabolomics and metagenomics.

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Randall Wolcott, M.D.

  Southwest Regional Wound Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: November 19, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

US (1)