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CompletedNCT00764023Updated Nov 26, 2015

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

An observational study in Infections, sponsored by Southwest Regional Wound Care Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-26.

Sponsored by Southwest Regional Wound Care Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
97
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infections

Keywords

  • wound debridement
  • removed orthopedic implants
  • removed catheters or shunts
  • excised tonsils, amputated tissue
  • sputum
  • stool
  • other excretions.
03

In context

Lead sponsor

Southwest Regional Wound Care Center is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
97 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • No treatment
  • human samples
06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

07

Study locations

1 site
  • Southwest Regional Wound Care Center
    Lubbock, Texas 79410, United States
08

References and documents

Publications

  • 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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00764023
Lead sponsor
Southwest Regional Wound Care Center
Responsible party
Randall Wolcott (Prinicipal Investigator, Southwest Regional Wound Care Center) — Principal investigator
First posted
Oct 1, 2008
Start date
Mar 2008
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Nov 26, 2015

Study contacts

Randall Wolcott, MD
principal investigator · Southwest Regional Wound Care Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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