Randomiserad kontrollerad studie för att undersöka kliniska resultat och associerade kostnader när PermeaDerm används som tillfälligt förband för operationssår
En prospektiv post-market multicenter randomiserad kontrollerad klinisk studie för att undersöka kliniska resultat och associerade kostnader när PermeaDerm används som tillfälligt förband för hantering av operationssår
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85008
- Valleywise Health
-
-
District of Columbia
-
Washington D.C., District of Columbia, Förenta staterna, 20010
- Medstar Washington Hospital Center
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30303
- Grady Memorial
-
-
Iowa
-
Iowa City, Iowa, Förenta staterna, 52242
- Univ of Iowa
-
-
Kansas
-
Kansas City, Kansas, Förenta staterna, 66160
- University of Kansas
-
-
Kentucky
-
Louisville, Kentucky, Förenta staterna, 40202
- Univ of Louisville Burn Center
-
-
Louisiana
-
New Orleans, Louisiana, Förenta staterna, 70112
- University Medical Center
-
-
New York
-
Rochester, New York, Förenta staterna, 14642
- University of Rochester
-
-
North Carolina
-
Winston-Salem, North Carolina, Förenta staterna, 27157
- Atrium Health Wake Forest Baptist
-
-
Ohio
-
Akron, Ohio, Förenta staterna, 44308
- Akron Children's Hospital
-
Columbus, Ohio, Förenta staterna, 43210
- Ohio State University
-
-
Tennessee
-
Memphis, Tennessee, Förenta staterna, 38163
- Regional One Firefighter's Burn Center
-
-
Virginia
-
Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Subjects must meet all the following criteria to be eligible for participation:
-
The patient's wound requires temporary dressing coverage after surgical excision and prior to autografting.
-
The patient has a surgical wound up to 30% (inclusive) total body surface area (TBSA).
-
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.
-
The patient is hospitalized within 3 days of injury.
-
The surgical excision occurs within 5 days post-injury.
-
The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
-
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).
-
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:
-
The study area has received prior surgical intervention.
-
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.
-
Clinical signs of wound infection at study area that in the investigator's opinion may compromise patient safety or trial objectives.
-
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).
-
The patient has any another condition, that in the investigator's opinion may compromise patient safety or the trial objectives.
-
The patient is unable to understand English or Spanish.
-
The patient has a known hypersensitivity to bovine-derived collagen materials, porcine, aloe vera materials, or contraindications to the frozen human cadaveric allograft.
-
The patient's life expectancy is less than 1 year.
-
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: PermeaDerm Temporary Biosynthetic Wound Matrix
|
Study participants randomized (1:1) to this arm will receive PermeaDerm Biosynthetic Wound Matrix prior to skin graft. |
|
Experimentell: Frozen Human Cadaveric Allograft (FHCA)
|
Study participant randomized (1:1) to this arm will receive Frozen Human Cadaveric Allograft (FHCA) prior to skin graft. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Reduction of Cost per Total Body Surface Area (TBSA)
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CTP012
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .