Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to test whether artificial skin graft can substitute autologous skin graft in current burn treatment. The main question it aims to answer is:
• Can artificial skin graft result in better wound healing compared to the current burn treatment; autologous skin graft?
You will:
If there is a comparison group: Researchers will compare autologous skin graft group to see the wound healing process
Burn caused by working accidents occurs mostly in the male population of productive age (68.68%). Up to this date, the only treatment for grade 2B-3 burns patients in Indonesia is skin transplantation taken from their own body (autologous skin graft). This treatment has several drawbacks in which repeated surgery is sometimes necessary, the source of skin in patients with wide area of burn is limited, and patients that are in the elder age and have comorbidities have high mortality risk.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STSG (Split-Thickness Skin Graft) | Sham Comparator | Patients treated with the standard treatment; autologous skin graft |
|
| Amnion Bilayer Only | Experimental | Patients treated with artificial graft only |
|
| Amnion Bilayer seeded with co-culture | Experimental | Patients treated with artificial graft seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Split-thickness skin graft | Procedure | Transplantation of autologous skin to burn area |
|
| Measure | Description | Time Frame |
|---|---|---|
| Burn thickness | Thickness of burn evaluation using Rule of 9 | Day of surgery |
| Burn thickness | Thickness of burn evaluation using Rule of 9 | Day 7 after surgery |
| Burn thickness | Thickness of burn evaluation using Rule of 9 | Day 14 after surgery |
| Burn thermography | Thermography evaluation using FLIRONE | Day of surgery |
| Burn thermography | Thermography evaluation using FLIRONE | Day 7 after surgery |
| Burn thermography | Thermography evaluation using FLIRONE | Day 14 after surgery |
| Systemic clinical evaluation | Mean arterial pressure measurement | Day of surgery |
| Systemic clinical evaluation | Mean arterial pressure measurement | Day 7 after surgery |
| Systemic clinical evaluation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUPN Cipto Mangunkusumo | Recruiting | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Artificial skin graft | Biological | Decellularized amnion membrane formed into 3-D matrix |
|
| Artificial skin graft co-culture | Biological | Decellularized amnion membrane formed into 3-D matrix seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells |
|
Mean arterial pressure measurement
| Day 14 after surgery |
| Systemic clinical evaluation | lactate measurement | Day of surgery |
| Systemic clinical evaluation | lactate measurement | Day 7 after surgery |
| Systemic clinical evaluation | lactate measurement | Day 14 after surgery |
| Systemic clinical evaluation | procalcitonin measurement | Day of surgery |
| Systemic clinical evaluation | procalcitonin measurement | Day 7 after surgery |
| Systemic clinical evaluation | procalcitonin measurement | Day 14 after surgery |
| Systemic clinical evaluation | urine excretion rate measurement | Day of surgery |
| Systemic clinical evaluation | urine excretion rate measurement | Day 7 after surgery |
| Systemic clinical evaluation | urine excretion rate measurement | Day 14 after surgery |
| Histoarchitecture evaluation | Haematoxylin & Eosin staining | Day of surgery |
| Histoarchitecture evaluation | Haematoxylin & Eosin staining | Day 14 after surgery |
| Histoarchitecture evaluation | Movat's Pentachrome staining | Day of surgery |
| Histoarchitecture evaluation | Movat's Pentachrome staining | Day 14 after surgery |
| Immunohistochemistry | collagen-1 labelling | Day of surgery |
| Immunohistochemistry | collagen-1 labelling | Day 14 after surgery |
| Immunohistochemistry | collagen-3 labelling | Day of surgery |
| Immunohistochemistry | collagen-3 labelling | Day 14 after surgery |
| Immunohistochemistry | von Willebrand labelling | Day of surgery |
| Immunohistochemistry | von Willebrand labelling | Day 14 after surgery |
| Immunohistochemistry | alpha-Smooth Muscle Actin labelling | Day of surgery |
| Immunohistochemistry | alpha-Smooth Muscle Actin labelling | Day 14 after surgery |
| Wound healing relative gene expression | TGFB1 | Day of surgery |
| Wound healing relative gene expression | TGFB1 | Day 14 after surgery |
| Wound healing relative gene expression | TGFB3 | Day of surgery |
| Wound healing relative gene expression | TGFB3 | Day 14 after surgery |
| Wound healing relative gene expression | Wnt4 | Day of surgery |
| Wound healing relative gene expression | Wnt4 | Day 14 after surgery |
| Wound healing relative gene expression | CTNNB1 | Day of surgery |
| Wound healing relative gene expression | CTNNB1 | Day 14 after surgery |
| Wound healing relative gene expression | MMP2 | Day of surgery |
| Wound healing relative gene expression | MMP2 | Day 14 after surgery |
| Wound healing relative gene expression | MMP9 | Day of surgery |
| Wound healing relative gene expression | MMP9 | Day 14 after surgery |