Status:
WITHDRAWN
Human Tissue Repository for Wound Care
Lead Sponsor:
3M
Conditions:
Human Tissue Repository
Eligibility:
All Genders
18-75 years
Brief Summary
The objective of this study is to create a Human Tissue Repository to be used as a resource for future tissue repair research at KCI USA, Inc.
Detailed Description
The study design is a multicenter study involving the collection of human biological specimens in Subjects with various wound classifications and types for the purpose of a Human Tissue Repository to ...
Eligibility Criteria
Inclusion
- Subject's wound is acute or chronic and classified as one of the following wound types: diabetic, pressure ulcer, burn, traumatic or dehisced, and Subject signs the separate informed consent form for the study. The consent process for tissue collection should occur separately from any surgical consent.
- Subject is reported to be physically and mentally able and willing to comply with the Protocol.
- Subject is between 18 - 75 years old.
Exclusion
- Reported presence of Human Immunodeficiency Virus.
- Reported presence of Acquired Immune Deficiency Syndrome.
- Reported presence of Hepatitis.
- Reported presence of cancer in the wound.
- Reported presence or suspected presence of infection (indicated by signs and symptoms of infection such as redness/swelling, or a positive culture, etc.)
- Presence of untreatable osteomyelitis.
- Presence of any other severe concurrent disease, which, in the judgment of the investigator, would make the subject inappropriate for entry into the study.
- Necrotic tissue with eschar present that cannot be debrided.
- Subject is unwilling or unable to comply with the protocol.
- Subject is a suspected or known intravenous drug user.
- Donation of tissue which, in the judgment of the investigator, may pose venous or arterial compromise.
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01432054
Last Update
August 1 2022
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