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A Prospective Analysis of Biofilm in Urinary Catheters Study

NCT ID: NCT01987336

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urinary Incontinence

Keywords

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Standard Foley Catheter

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southwest Regional Wound Care Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Randall Wolcott, M.D.

Role: PRINCIPAL_INVESTIGATOR

Southwest Regional Wound Care Center

Locations

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Southwest Regional Wound Care Center

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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56-RW-022

Identifier Type: -

Identifier Source: org_study_id