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

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

Debridement Samples being collected for future or immediate research purposes.

Study Overview

• Status: Unknown
• Conditions: Wound

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.

• Study Type: Observational
• Enrollment (Anticipated): 829

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79410
      • Soutwest Regional Wound Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Southwest Regional Wound Care Center

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Anticipated): January 18, 2021
• Study Completion (Anticipated): January 18, 2021

Study Registration Dates

• First Submitted: September 24, 2008
• First Submitted That Met QC Criteria: September 24, 2008
• First Posted (Estimate): September 25, 2008

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: open wound; study of debridement tissue for research purposes.
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 56-RW-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO