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A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune, or Host-Microbe Scientific Study

NCT ID: NCT00764023

Last Updated: 2015-11-26

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

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-01-31

Brief Summary

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The intent of this protocol is to salvage human-related material that is normally destined for destruction, so it can be used in infection-related scientific studies. This clinical material can be studied in order to better understand the molecular, cellular, or ecological components of the infected or potentially infected tissue or device.

Detailed Description

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The samples can include material such as wound debridement, removed orthopedic implants, removed catheters or shunts, excised tonsils, amputated tissue, sputum, stool, or other excretions. The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques. The studies can examine microbes or the host's response to microbes by examining the nucleic acids (e.g. 16S DNA, mRNA), proteins, or other metabolites.

Conditions

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Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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No treatment

No interventions assigned to this group

human samples

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. The Subject must be 18 years of age or older
2. The Subject must be mentally competent as determined by the Investigator, or have a Legally Authorized Representative.

Exclusion Criteria

1. The Subject may not be currently incarcerated.
2. The Subject may not be knowingly pregnant.
3. The Subject may not be institutionalized.
4. The Subject may not be an employee or student of the investigator or sponsor.
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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Randall Wolcott

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randall Wolcott, MD

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

References

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A Possible Role of Bacterial Biofilm in the Pathogenesis of Atherosclerosis Bacteriol Parasitol Volume 3 • Issue 1 • 1000127 ISSN:2155-9597 JBP an open access journal

Reference Type RESULT

Other Identifiers

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56-RW-010

Identifier Type: -

Identifier Source: org_study_id