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Completed

NCT Number: NCT01987336

A Prospective Analysis 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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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Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Southwest Regional Wound Care Center

Other

Registry information

Official study title

A Prospective Anaylsis of Biofilm in Urinary Catheters Study

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 19, 2013
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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