Obtaining and Storing Wound Debridment Samples For Immediate or Future Wound-Related Scientific Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT00759499
First received: September 24, 2008
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

Debridement Samples being collected for future or immediate research purposes.


Condition
Wound

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Obtaining and Storing Wound Debridment Samples for Immediate or Future Wound-Related Scientific Study

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

Primary Outcome Measures:
  • The intent of this protocol is to salvage wound material that is normally destined for destruction, so it can be used in wound-related scientific studies. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

The intent of this protocol is to salvage wound material that is normally destined for destruction, so it can be used in wound-related scientific studies


Estimated Enrollment: 829
Study Start Date: January 2007
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Debridement
The intent of this protocol is to salvage wound material that is normally destined for destruction, so it can be used in wound-related scientific studies. This clinical wound material can be studied in order to better understand the molecular, cellular, or ecological components of the wound system. These studies may be able to provide important insights into the keys of wound healing, wound persistence, or wound deterioration.

Detailed Description:

Inclusion Criteria

  1. The subject must have a full thickness wound.
  2. The subject must be a candidate for sharp debridement.
  3. The subject must be 18 years of age or older
  4. The subject must be mentally competent as determined by the Principal Investigator.

Exclusion Criteria

1. The subject may not be currently incarcerated or pregnant.

  • Nursing home and hospitalized subjects will not be excluded from this study because these subjects represent a large part of the wounded population.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects will be identified because their wound(s) possesses something of special interest. A special interest wound can include, but will not be limited to wounds that are rapidly deteriorating, wounds diagnosed as pyoderma gangrenosum, wounds showing unusually rapid wound healing, wounds with abnormal microorganisms, non-healing wounds, young wounds, and others.

Criteria

Inclusion Criteria:

  • The subject must have a full thickness wound.
  • The subject must be a candidate for sharp debridement.
  • The subject must be 18 years of age or older
  • The subject must be mentally competent as determined by the Principal Investigator

Exclusion Criteria:

  • The subject may not be currently incarcerated or pregnant.
  • Nursing home and hospitalized subjects will not be excluded from this study because these subjects represent a large part of the wounded population.
  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: NCT00759499

Locations
United States, Texas
Soutwest Regional Wound Care Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Southwest Regional Wound Care Center
Investigators
Principal Investigator: Randall D Wolcott, M.D. Southwest Regional Wound Care Center
  More Information

No publications provided

Responsible Party: Randall Wolcott, Principal Investigator, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT00759499     History of Changes
Other Study ID Numbers: 56-RW-004
Study First Received: September 24, 2008
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Southwest Regional Wound Care Center:
study of debridement tissue for research purposes.
open wound

ClinicalTrials.gov processed this record on July 26, 2014