A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune,or Host-Microbe Scientific Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques.
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Randall Wolcott
Prinicipal Investigator
Southwest Regional Wound Care Center