Multisenter enarmsprøve for å undersøke kliniske resultater når Cohealyx™ brukes til sår i full tykkelse (Cohealyx I)
En prospektiv multisenter enarms klinisk studie for å undersøke kliniske resultater når Cohealyx™ brukes til behandling av sår i full tykkelse etter kirurgisk eksisjon
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Alabama
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Mobile, Alabama, Forente stater, 36604
- University of South Alabama
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Arizona
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Phoenix, Arizona, Forente stater, 85008
- Valleywise Health
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Tucson, Arizona, Forente stater, 85724
- University of Arizona
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20010
- Medstar Washington Hospital Center
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- Univ of Iowa
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- The University of Kansas Health
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- University of Louisville
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Louisiana
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New Orleans, Louisiana, Forente stater, 70112
- University Medical Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Missouri
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Springfield, Missouri, Forente stater, 65804
- Mercy Hospital Springfield
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Nevada
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Las Vegas, Nevada, Forente stater, 89102
- University Medical Center of Southern Nevada
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New York
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Rochester, New York, Forente stater, 14642
- University of Rochester
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Ohio
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Akron, Ohio, Forente stater, 44308
- Akron Children's Hospital
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Columbus, Ohio, Forente stater, 43210
- Ohio State University
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
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Texas
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Fort Worth, Texas, Forente stater, 76104
- JPS Health Network
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Lubbock, Texas, Forente stater, 79430
- Texas Tech University
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Virginia
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Richmond, Virginia, Forente stater, 23225
- Chippenham Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cohealyx
Cohealyx application post surgical excision |
Cohealyx application, followed by autologous split-thickness skin graft |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CTP011
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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