Biological Skin Graft With Keratinocyte-stem Cell Co-cultre for Burn Patients
NCT ID: NCT05652816
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
20 participants
INTERVENTIONAL
2022-09-06
2024-12-31
Brief Summary
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• Can artificial skin graft result in better wound healing compared to the current burn treatment; autologous skin graft?
You will:
* Undergo debridement surgery
* Receive artificial skin graft as an alternative to autologous skin graft
* Undergo biopsy procedure of burn area
If there is a comparison group: Researchers will compare autologous skin graft group to see the wound healing process
Detailed Description
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In order to find an alternative for autologous skin graft therapy, a combination of tissue engineering and stem cell therapy is used to invent an artificial skin graft. The present study attempts to evaluate the efficacy of artificial skin graft seeded with autologous keratinocyte and stem cells towards wound healing in burn patients. The artificial graft used in this study is amnion bilayer; a graft that was decellularized to remove donor's cells and then layered to form into 3-D.
To evaluate the efficacy, biopsies are taken from the burn area of patients to evaluate the histoarchitecture of patients' tissue by histological staining (H\&E and Movat's pentachrome, IHC collagen I, collagen III, vWF, and alpha-SMA) and measure the relative gene expression by qPCR. For clinical data, burn area calculation using Rule of 9 method and thermography measurement using FLIRONE. Furthermore, systemic evaluation of patients are done by monitoring the procalcitonin, lactate, mean arterial pressure, gradation of wound, and sensory of burn area. The evaluation and measurement mentioned above are then compared to patients treated with the current available therapy; autologous skin graft. The artificial skin graft is hoped to result in equal, if not better, wound healing in burn patients compared to autologous skin graft. The investigators hope that artificial skin graft can be an option, other than autologous skin graft, in treating burn patients in the future.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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STSG (Split-Thickness Skin Graft)
Patients treated with the standard treatment; autologous skin graft
Split-thickness skin graft
Transplantation of autologous skin to burn area
Amnion Bilayer Only
Patients treated with artificial graft only
Artificial skin graft
Decellularized amnion membrane formed into 3-D matrix
Amnion Bilayer seeded with co-culture
Patients treated with artificial graft seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells
Artificial skin graft co-culture
Decellularized amnion membrane formed into 3-D matrix seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells
Interventions
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Split-thickness skin graft
Transplantation of autologous skin to burn area
Artificial skin graft
Decellularized amnion membrane formed into 3-D matrix
Artificial skin graft co-culture
Decellularized amnion membrane formed into 3-D matrix seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells
Eligibility Criteria
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Inclusion Criteria
* Area of burn \<50%
* Acute phase burn (\<120 hrs)
* Have not undergo any surgery for burn treatment
Exclusion Criteria
* Have comorbidities
18 Years
55 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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dr. Aditya Wardhana
Head of Burns Unit, Cipto Mangunkusumo National Hospital
Locations
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RSUPN Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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Facility Contacts
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Aditya Wardhana, MD
Role: primary
Normalina Sandora, PhD
Role: backup
Other Identifiers
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KET-866/ETIK/2021
Identifier Type: -
Identifier Source: org_study_id