A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune, or Host-Microbe Scientific Study
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Purpose
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.
| Condition |
|---|
|
Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune,or Host-Microbe Scientific Study |
- The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| No treatment |
| human samples |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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:
- The Subject must be 18 years of age or older
- The Subject must be mentally competent as determined by the Investigator, or have a Legally Authorized Representative.
Exclusion Criteria:
- The Subject may not be currently incarcerated.
- The Subject may not be knowingly pregnant.
- The Subject may not be institutionalized.
- The Subject may not be an employee or student of the investigator or sponsor.
Contacts and Locations| Contact: Randall Wolcott, MD | 806-793-8869 | randy@randallwolcott.com |
| Contact: Lisa Morrow, LBSW | 806-793-8869 | lisa@randallwolcott.com |
| United States, Texas | |
| Southwest Regional Wound Care Center | Recruiting |
| Lubbock, Texas, United States, 79410 | |
| Contact: Randall Wolcott, MD 806-793-8869 randy@randallwolcott.com | |
| Contact: Lisa Morrow, LBSW 806-793-8869 lisa@randallwolcott.com | |
| Principal Investigator: Randall Wolcott, MD | |
| Principal Investigator: | Randall Wolcott, MD | Southwest Regional Wound Care Center |
More Information
No publications provided
| Responsible Party: | Randall Wolcott, Prinicipal Investigator, Southwest Regional Wound Care Center |
| ClinicalTrials.gov Identifier: | NCT00764023 History of Changes |
| Other Study ID Numbers: | 56-RW-010 |
| Study First Received: | September 30, 2008 |
| Last Updated: | September 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Southwest Regional Wound Care Center:
|
wound debridement removed orthopedic implants removed catheters or shunts excised tonsils, amputated tissue |
sputum stool other excretions. |
ClinicalTrials.gov processed this record on May 16, 2013