Obtaining and Storing Wound Debridment Samples For Immediate or Future Wound-Related Scientific Study
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| First Received Date ICMJE | September 24, 2008 | ||||
| Last Updated Date | March 4, 2013 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00759499 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Obtaining and Storing Wound Debridment Samples For Immediate or Future Wound-Related Scientific Study | ||||
| Official Title ICMJE | Obtaining and Storing Wound Debridment Samples for Immediate or Future Wound-Related Scientific Study | ||||
| Brief Summary | Debridement Samples being collected for future or immediate research purposes. |
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| Detailed Description | Inclusion Criteria
Exclusion Criteria 1. The subject may not be currently incarcerated or pregnant.
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: 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 |
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| 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. |
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| Condition ICMJE | Wound | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 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. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 829 | ||||
| Estimated Completion Date | January 2014 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00759499 | ||||
| Other Study ID Numbers ICMJE | 56-RW-004 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Randall Wolcott, Southwest Regional Wound Care Center | ||||
| Study Sponsor ICMJE | Southwest Regional Wound Care Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Southwest Regional Wound Care Center | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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