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:
NCT00764023
First received: September 30, 2008
Last updated: November 12, 2013
Last verified: November 2013
  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

Further study details as provided by Southwest Regional Wound Care Center:

Primary Outcome Measures:
  • 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


Enrollment: 97
Study Start Date: March 2008
Study Completion Date: January 2013
Primary Completion Date: January 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
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764023

Locations
United States, Texas
Southwest Regional Wound Care Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Southwest Regional Wound Care Center
Investigators
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: November 12, 2013
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 September 16, 2014