- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01432054
Human Tissue Repository for Wound Care
July 29, 2022 updated by: 3M
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.
Study Overview
Status
Withdrawn
Conditions
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 be used as a resource for future tissue repair research at KCI USA, Inc. Subjects participating in this study will have a 6mm tissue punch biopsy or equivalent tissue specimen harvested from the healthiest margin of the wound.
Tissue collection may occur at Visits 2, 3, 4 and 5. Visit 2 may be combined with Screening, Visit 1. Subjects will have a minimum of one (1) and a maximum of four (4) specimen collection visits.
Specimens may be collected from one or multiple different tissues (connective tissue, muscle, bone, and dermis) at any or all visits.
Each specimen will be placed in a separate appropriate vial.
Necrotic tissue with eschar and bodily fluids such as blood, wound fluid or sputum will not be collected.
Tissue from healthy, healing wounds will also be accepted.
Tissue collection visits shall occur at least twenty-four (24) hours apart.
Ten (10) to twenty-five (25) percent of the sites will be selected to collect all the specimens in cryovials containing a pre-aliquoted amount (1.5mL) of RNAlater.
Ten (10) to twenty-five (25) percent of the sites will be selected to collect all the specimens in cryovials containing a pre-aliquoted amount of HypoThermosol.
The remaining sites will collect all the specimens in a vial containing no diluents.
All samples will be coded by the collection site prior to shipment to KCI.
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Eligible subjects with acute or chronic wounds and whose wounds encompass one of the following wound types will be enrolled: traumatic, diabetic, pressure ulcer, burns, or dehisced wounds.
Enrollment will continue up to 5 years.
KCI may determine at any time that sufficient samples have been obtained and cease enrollment.
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The study design is a collection of human biological specimens in Subjects with various wound classifications and types for the purpose of a Human Tissue Repository to be used as a resource for future tissue repair research at KCI USA, Inc
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 8, 2011
First Submitted That Met QC Criteria
September 9, 2011
First Posted (Estimate)
September 12, 2011
Study Record Updates
Last Update Posted (Actual)
August 1, 2022
Last Update Submitted That Met QC Criteria
July 29, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VACP2007-24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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