Essai multicentrique à un seul bras pour étudier les résultats cliniques lorsque Cohealyx™ est utilisé pour les plaies de pleine épaisseur (Cohealyx I)
Une étude clinique prospective multicentrique à un seul bras pour étudier les résultats cliniques lorsque Cohealyx ™ est utilisé pour la prise en charge des plaies de pleine épaisseur après une excision chirurgicale
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Alabama
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Mobile, Alabama, États-Unis, 36604
- University of South Alabama
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Arizona
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Phoenix, Arizona, États-Unis, 85008
- Valleywise Health
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Tucson, Arizona, États-Unis, 85724
- University of Arizona
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20010
- Medstar Washington Hospital Center
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Iowa
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Iowa City, Iowa, États-Unis, 52242
- Univ of Iowa
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- The University of Kansas Health
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Kentucky
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Louisville, Kentucky, États-Unis, 40202
- University of Louisville
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Louisiana
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New Orleans, Louisiana, États-Unis, 70112
- University Medical Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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Missouri
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Springfield, Missouri, États-Unis, 65804
- Mercy Hospital Springfield
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Nevada
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Las Vegas, Nevada, États-Unis, 89102
- University Medical Center of Southern Nevada
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New York
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Rochester, New York, États-Unis, 14642
- University of Rochester
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Ohio
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Akron, Ohio, États-Unis, 44308
- Akron Children's Hospital
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Columbus, Ohio, États-Unis, 43210
- Ohio State University
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
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Texas
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Fort Worth, Texas, États-Unis, 76104
- JPS Health Network
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Lubbock, Texas, États-Unis, 79430
- Texas Tech University
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Virginia
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Richmond, Virginia, États-Unis, 23225
- Chippenham Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Cohealyx
Cohealyx application post surgical excision |
Cohealyx application, followed by autologous split-thickness skin graft |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time for Cohealyx to generate tissue capable of supporting definitive closure
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CTP011
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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