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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00764023
Enrollment
97
Registered
2008-10-01
Start date
2008-03-31
Completion date
2013-01-31
Last updated
2015-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections

Keywords

wound debridement, removed orthopedic implants, removed catheters or shunts, excised tonsils, amputated tissue, sputum, stool, other excretions.

Brief summary

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

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.

Interventions

None listed

Sponsors

Southwest Regional Wound Care Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques.1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026