Human Tissue RepositoryNCT01432054
Human Tissue Repository for Wound Care
An observational study of Human Tissue Repository, run by 3M.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Human Tissue Repository
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
About this study
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.
Read the 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.
- Conditions
- Human Tissue Repository
- Keywords
- Human Tissue Repository
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
Why it stopped: business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Tissue RepositoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3M
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432054
- Sponsor's protocol ID
- VACP2007-24
- Status last verified
- Jul 2022
- First submitted
- 8 Sep 2011
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Tissue Repository for Wound Care
- ClinicalTrials.gov ID
- NCT01432054
- Acronym / sponsor ID
- VACP2007-24
- Conditions
- Human Tissue Repository
- Keywords
- Human Tissue Repository
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- 3MIndustry (pharma, biotech, devices)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Tissue Repository, run by 3M.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.