Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT00765141
First received: September 30, 2008
Last updated: September 6, 2011
Last verified: September 2011
History of Changes

September 30, 2008
September 6, 2011
June 2008
March 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00765141 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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. These studies may be able to provide important insights into the keys of chronic infections, complex infections, medical biofilms, pathogen ecology, and healing.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
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.
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.
Infection
Not Provided
No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
0
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The Subject must be 18 years of age or older.
  • The Subject must be mentally competent as determined by the Investigator.

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00765141
56-RW-011
Yes
Randall Wolcott, Southwest Regional Wound Care Center
Southwest Regional Wound Care Center
Not Provided
Principal Investigator: Randall Wolcott, MD Southwest Regional Wound Care Center
Southwest Regional Wound Care Center
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP