NCT00764023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

4.8 years

First QC Date

September 30, 2008

Last Update Submit

November 24, 2015

Conditions

Infections

Keywords

wound debridementremoved orthopedic implantsremoved catheters or shuntsexcised tonsils, amputated tissuesputumstoolother excretions.

Outcome Measures

Primary Outcomes (1)

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

    1 year

Study Arms (2)

No treatment

human samples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

Related Publications (1)

  • 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

    RESULT

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

MeSH Terms

Conditions

Infections

Study Officials

  • Randall Wolcott, MD

    Southwest Regional Wound Care Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations

US(1)