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A Prospective Analysis of Biofilm in Urinary Catheters Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987336
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Southwest Regional Wound Care Center

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.

Condition or disease
Urinary Incontinence

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.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Anaylsis of Biofilm in Urinary Catheters Study
Study Start Date : March 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015



Primary Outcome Measures :
  1. 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


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects who require a standard foley catheter.
Criteria

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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987336


Locations
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United States, Texas
Southwest Regional Wound Care Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Southwest Regional Wound Care Center
Investigators
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Principal Investigator: Randall Wolcott, M.D. Southwest Regional Wound Care Center
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Responsible Party: Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT01987336    
Other Study ID Numbers: 56-RW-022
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by Southwest Regional Wound Care Center:
Standard Foley Catheter
Additional relevant MeSH terms:
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Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations