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: * 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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Transplantation of autologous skin to burn area
Decellularized amnion membrane formed into 3-D matrix
Decellularized amnion membrane formed into 3-D matrix seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells
RSUPN Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, Indonesia
RECRUITINGBurn thickness
Thickness of burn evaluation using Rule of 9
Time frame: Day of surgery
Burn thickness
Thickness of burn evaluation using Rule of 9
Time frame: Day 7 after surgery
Burn thickness
Thickness of burn evaluation using Rule of 9
Time frame: Day 14 after surgery
Burn thermography
Thermography evaluation using FLIRONE
Time frame: Day of surgery
Burn thermography
Thermography evaluation using FLIRONE
Time frame: Day 7 after surgery
Burn thermography
Thermography evaluation using FLIRONE
Time frame: Day 14 after surgery
Systemic clinical evaluation
Mean arterial pressure measurement
Time frame: Day of surgery
Systemic clinical evaluation
Mean arterial pressure measurement
Time frame: Day 7 after surgery
Systemic clinical evaluation
Mean arterial pressure measurement
Time frame: Day 14 after surgery
Systemic clinical evaluation
lactate measurement
Time frame: Day of surgery
Systemic clinical evaluation
lactate measurement
Time frame: Day 7 after surgery
Systemic clinical evaluation
lactate measurement
Time frame: Day 14 after surgery
Systemic clinical evaluation
procalcitonin measurement
Time frame: Day of surgery
Systemic clinical evaluation
procalcitonin measurement
Time frame: Day 7 after surgery
Systemic clinical evaluation
procalcitonin measurement
Time frame: Day 14 after surgery
Systemic clinical evaluation
urine excretion rate measurement
Time frame: Day of surgery
Systemic clinical evaluation
urine excretion rate measurement
Time frame: Day 7 after surgery
Systemic clinical evaluation
urine excretion rate measurement
Time frame: Day 14 after surgery
Histoarchitecture evaluation
Haematoxylin \& Eosin staining
Time frame: Day of surgery
Histoarchitecture evaluation
Haematoxylin \& Eosin staining
Time frame: Day 14 after surgery
Histoarchitecture evaluation
Movat's Pentachrome staining
Time frame: Day of surgery
Histoarchitecture evaluation
Movat's Pentachrome staining
Time frame: Day 14 after surgery
Immunohistochemistry
collagen-1 labelling
Time frame: Day of surgery
Immunohistochemistry
collagen-1 labelling
Time frame: Day 14 after surgery
Immunohistochemistry
collagen-3 labelling
Time frame: Day of surgery
Immunohistochemistry
collagen-3 labelling
Time frame: Day 14 after surgery
Immunohistochemistry
von Willebrand labelling
Time frame: Day of surgery
Immunohistochemistry
von Willebrand labelling
Time frame: Day 14 after surgery
Immunohistochemistry
alpha-Smooth Muscle Actin labelling
Time frame: Day of surgery
Immunohistochemistry
alpha-Smooth Muscle Actin labelling
Time frame: Day 14 after surgery
Wound healing relative gene expression
TGFB1
Time frame: Day of surgery
Wound healing relative gene expression
TGFB1
Time frame: Day 14 after surgery
Wound healing relative gene expression
TGFB3
Time frame: Day of surgery
Wound healing relative gene expression
TGFB3
Time frame: Day 14 after surgery
Wound healing relative gene expression
Wnt4
Time frame: Day of surgery
Wound healing relative gene expression
Wnt4
Time frame: Day 14 after surgery
Wound healing relative gene expression
CTNNB1
Time frame: Day of surgery
Wound healing relative gene expression
CTNNB1
Time frame: Day 14 after surgery
Wound healing relative gene expression
MMP2
Time frame: Day of surgery
Wound healing relative gene expression
MMP2
Time frame: Day 14 after surgery
Wound healing relative gene expression
MMP9
Time frame: Day of surgery
Wound healing relative gene expression
MMP9
Time frame: Day 14 after surgery
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