- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01432054
Human Tissue Repository for Wound Care
29. juli 2022 opdateret af: 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.
Studieoversigt
Status
Trukket tilbage
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Datoer for studieregistrering
Først indsendt
8. september 2011
Først indsendt, der opfyldte QC-kriterier
9. september 2011
Først opslået (Skøn)
12. september 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. august 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juli 2022
Sidst verificeret
1. juli 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- VACP2007-24
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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