Essai contrôlé randomisé pour étudier les résultats cliniques et les coûts associés lorsque PermeaDerm est utilisé comme pansement temporaire pour les plaies chirurgicales
Une étude clinique prospective contrôlée randomisée multicentrique post-commercialisation pour étudier les résultats cliniques et les coûts associés lorsque PermeaDerm est utilisé comme pansement temporaire pour la prise en charge des plaies chirurgicales
The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound. The researchers will review cost and other treatment results including how well both temporary dressings attach to the skin, how prepared the wound bed is to receive a skin graft, how long it takes for the skin to be ready to receive a skin graft, how well the skin graft takes and any complications. Patients will first have the temporary dressing applied to their wound, then a few days later, a skin graft will be performed. Patients will have photos of their wounds taken throughout the study including at all the clinic check-ups with the last check-up occurring about 8 weeks after treatment.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a prospective two-arm randomized multicenter controlled study to evaluate the clinical outcomes and economic impact of PermeaDerm and frozen human cadaveric allograft (FHCA) when they are used as a temporary dressing on surgical wounds where autografting is clinically indicated.
Patients hospitalized within 3 days of injury with a surgical wound up to 30% (inclusive) total body surface area (TBSA) will be considered for participation in this study.
Patients will undergo surgical excision within five days post-injury and will be randomly assigned (1:1) to receive PermeaDerm or FHCA as a temporary dressing. One contiguous area will be selected by the investigator as the study treatment area. Any other areas that require a temporary dressing must be dressed per the randomization.
In addition to economic impact, the two temporary dressings will be compared with respect to adherence, wound bed preparation, time to autografting, graft take, and safety-related adverse events.
Following placement of the temporary dressing, investigators will evaluate the wound every 2-3 days. The temporary dressing may be replaced, per the randomization, as clinically indicated. When the study area is ready for autografting, the temporary dressing will be removed, and the study area will be autografted per the investigative site's standard of care. The donor area(s) may be dressed in PermeaDerm or the investigative site's standard of care.
Post-autografting, subjects will be followed for 8 weeks. Treatment-related and serious adverse events will be reported through the duration of the study. At all visits, subjects' study treatment areas and donor sites that are 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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Arizona
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Phoenix, Arizona, États-Unis, 85008
- Valleywise Health
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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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-
Georgia
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Atlanta, Georgia, États-Unis, 30303
- Grady Memorial
-
-
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
- University of Kansas
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-
Kentucky
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Louisville, Kentucky, États-Unis, 40202
- Univ of Louisville Burn Center
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-
Louisiana
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New Orleans, Louisiana, États-Unis, 70112
- University Medical Center
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-
New York
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Rochester, New York, États-Unis, 14642
- University of Rochester
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-
North Carolina
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Winston-Salem, North Carolina, États-Unis, 27157
- Atrium Health Wake Forest Baptist
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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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Tennessee
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Memphis, Tennessee, États-Unis, 38163
- Regional One Firefighter's Burn Center
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Virginia
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth University
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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's wound requires temporary dressing coverage after surgical excision and prior to autografting.
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The patient has a surgical wound up to 30% (inclusive) total body surface area (TBSA).
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The study area is a contiguous area. If the patient has other areas (non-study treatment area) that require temporary dressing, these areas must also be dressed according to the randomization.
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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 (8 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:
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The study area has received prior surgical intervention.
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The patient is currently using medications or treatments such as systemic corticosteroids, chemotherapy, or immunosuppressants, that in the investigator's opinion may compromise patient safety or trial objectives.
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Clinical signs of wound infection at study area that in the investigator's opinion may compromise patient safety or trial objectives.
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The patient has any of the following
- morbid obesity (BMI >40),
- immunodeficiency,
- venous insufficiency/PVD of the lower extremities (when study area is also in this location),
- chronic malnourishment,
- inhalation injury (>Grade 1 based on AIS grading scale),
- current abuser of alcohol and/or illicit drugs based upon medical history and/or lab results,
- diabetes mellitus with HbA1c >9.0%, and/or
- advanced renal disease (eGFR <59) or liver disease (LFTs >2.5 times the upper limit).
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The patient has any another condition, that in the investigator's opinion may compromise patient safety or the trial objectives.
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The patient is unable to understand English or Spanish.
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The patient has a known hypersensitivity to bovine-derived collagen materials, porcine, aloe vera materials, or contraindications to the frozen human cadaveric allograft.
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The patient's life expectancy is less than 1 year.
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Matrice de plaie biosynthétique temporaire PermeaDerm
|
Study participants randomized (1:1) to this arm will receive PermeaDerm Biosynthetic Wound Matrix prior to skin graft. |
|
Expérimental: Allogreffe cadavérique humaine congelée (FHCA)
|
Study participant randomized (1:1) to this arm will receive Frozen Human Cadaveric Allograft (FHCA) prior to skin graft. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reduction of Cost per Total Body Surface Area (TBSA)
Délai: 8 weeks post treatment.
|
The reduction of cost per TBSA when PermeaDerm is used as a temporary dressing. The reduction in cost is hypothesized to be superior for PermeaDerm as compared to FHCA. |
8 weeks post treatment.
|
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
- CTP012
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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