Multicenter enkeltarmsforsøg for at undersøge kliniske resultater, når Cohealyx™ bruges til sår i fuld tykkelse (Cohealyx I)
Et prospektivt multicenter enkeltarms klinisk undersøgelse for at undersøge kliniske resultater, når Cohealyx™ bruges til behandling af fuldtykkelsessår efter kirurgisk excision
The goal of this study is to look at clinical outcomes when Cohealyx Collagen Matrix is used to treat full thickness wounds after surgical excision in patients that require a skin graft to heal their wounds. The main question it aims to answer is how long does it take for Cohealyx to support definitive closure.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a prospective single-arm post-market multicenter study to evaluate clinical outcomes of Cohealyx when used to manage full thickness wounds post-surgical excision. A systematic literature review and meta-analysis were conducted to establish a performance goal for the primary effectiveness endpoint (time to autografting).
Patients with a full thickness wound where autografting is clinically indicated will be considered for participation in this study. Patients will undergo a staged surgical procedure for wound closure. In the first surgery, Cohealyx will be applied to the surgically excised wound bed within 5-days post-injury.
Following placement of Cohealyx, investigators will evaluate the wound every 3 days. Once Cohealyx has successfully integrated into the wound bed, as indicated by a robust vascularized tissue bed, the wound bed will be prepared and autografted per the investigative site's standard of care.
The study area will be evaluated with respect to Cohealyx integration, time to autografting, autograft take, healing, and safety-related adverse events.
Post-autografting, subjects will be followed for 6.5 months. Treatment-related and serious adverse events will be reported through the duration of the study. At all visits, subjects' study treatment areas as well as any donor sites dressed in PermeaDerm will be documented using digital photography.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Alabama
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Mobile, Alabama, Forenede Stater, 36604
- University of South Alabama
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Arizona
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Phoenix, Arizona, Forenede Stater, 85008
- Valleywise Health
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Tucson, Arizona, Forenede Stater, 85724
- University of Arizona
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- Medstar Washington Hospital Center
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Univ of Iowa
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- The University of Kansas Health
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- University of Louisville
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- University Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Missouri
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Springfield, Missouri, Forenede Stater, 65804
- Mercy Hospital Springfield
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- University Medical Center of Southern Nevada
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New York
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Rochester, New York, Forenede Stater, 14642
- University of Rochester
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Ohio
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Akron, Ohio, Forenede Stater, 44308
- Akron Children's Hospital
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Texas
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Fort Worth, Texas, Forenede Stater, 76104
- JPS Health Network
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Lubbock, Texas, Forenede Stater, 79430
- Texas Tech University
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Virginia
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Richmond, Virginia, Forenede Stater, 23225
- Chippenham Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Subjects must meet all the following criteria to be eligible for participation:
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The patient has a staged surgical procedure planned that requires autografting for treatment of a full thickness wound.
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The patient is hospitalized within 3 days of injury.
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The surgical excision occurs within 5 days post-injury.
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The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
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The patient (or parent/guardian/legally authorized representative) agrees to abstain from any other treatment of the study area or enrollment in another interventional clinical trial for the duration of his/her participation in the study (26 weeks post-autografting).
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In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:
- Understand the full nature and purpose of the study, including possible risks and adverse events,
- Understand instructions, and
- Provide voluntary written informed consent
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible for participation:
- Clinical signs of wound infection at study area.
- The patient has a medical condition, is using medications or receiving treatments (e.g., immune deficiency) that may compromise patient safety or the trial evaluations or objectives.
- The patient is unable to understand English or Spanish.
- The patient has a known hypersensitivity to bovine-derived collagen, porcine, or aloe vera materials.
- Presence of a medical condition where the patient's life expectancy is less than 1 year (e.g., malignancy).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cohealyx
Cohealyx application post surgical excision |
Cohealyx application, followed by autologous split-thickness skin graft |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time for Cohealyx to generate tissue capable of supporting definitive closure
Tidsramme: Up to 30 days
|
Defined as the number of days from placement of Cohealyx until placement of an autologous split-thickness skin graft |
Up to 30 days
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CTP011
Plan for individuelle deltagerdata (IPD)
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