- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01987336
A Prospective Analysis of Biofilm in Urinary Catheters Study
December 10, 2015 updated by: Southwest Regional Wound Care Center
A Prospective Anaylsis of Biofilm in Urinary Catheters Study
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
9
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Lubbock, Texas, United States, 79410
- Southwest Regional Wound Care Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects who require a standard foley catheter.
Description
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:
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter.
Time Frame: Over a period of 20 weeks
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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
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Over a period of 20 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Randall Wolcott, M.D., Southwest Regional Wound Care Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
March 4, 2013
First Submitted That Met QC Criteria
November 12, 2013
First Posted (Estimate)
November 19, 2013
Study Record Updates
Last Update Posted (Estimate)
December 11, 2015
Last Update Submitted That Met QC Criteria
December 10, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 56-RW-022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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