Substitute Graft for Burns Using Biological Graft Seeded With Autologous Keratinocyte Co-cultured With Stem Cells
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Burn thermography
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 - 55
- •Area of burn <50%
- •Acute phase burn (<120 hrs)
- •Have not undergo any surgery for burn treatment
排除标准
- •Immunocompromised
- •Have comorbidities
结局指标
主要结局
Burn thermography
时间窗: Day 14 after surgery
Thermography evaluation using FLIRONE
Burn thickness
时间窗: Day 14 after surgery
Thickness of burn evaluation using Rule of 9
Systemic clinical evaluation
时间窗: Day 14 after surgery
Mean arterial pressure measurement
Histoarchitecture evaluation
时间窗: Day 14 after surgery
Haematoxylin \& Eosin staining
Immunohistochemistry
时间窗: Day 14 after surgery
collagen-1 labelling
Wound healing relative gene expression
时间窗: Day 14 after surgery
TGFB1
次要结局
未报告次要终点
研究者
dr. Aditya Wardhana
Head of Burns Unit, Cipto Mangunkusumo National Hospital
Indonesia University