Clinical trial NCT05652816: Biological Skin Graft With Keratinocyte-stem Cell Co-cultre for Burn Patients
Official title: Substitute Graft for Burns Using Biological Graft Seeded With Autologous Keratinocyte Co-cultured With Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Burn Degree Second
Burn Degree Third
Keywords: artificial skin graft
keratinocyte
amnion epithelial stem cells
burn
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18 - 55
* Area of burn \<50%
* Acute phase burn (\<120 hrs)
* Have not undergo any surgery for burn treatment

Exclusion Criteria:

* Immunocompromised
* Have comorbidities

Primary outcomes:
measure: Burn thickness
timeFrame: Day of surgery
measure: Burn thickness
timeFrame: Day 7 after surgery
measure: Burn thickness
timeFrame: Day 14 after surgery
measure: Burn thermography
timeFrame: Day of surgery
measure: Burn thermography
timeFrame: Day 7 after surgery
measure: Burn thermography
timeFrame: Day 14 after surgery
measure: Systemic clinical evaluation
timeFrame: Day of surgery
measure: Systemic clinical evaluation
timeFrame: Day 7 after surgery
measure: Systemic clinical evaluation
timeFrame: Day 14 after surgery
measure: Systemic clinical evaluation
timeFrame: Day of surgery
measure: Systemic clinical evaluation
timeFrame: Day 7 after surgery
measure: Systemic clinical evaluation
timeFrame: Day 14 after surgery
measure: Systemic clinical evaluation
timeFrame: Day of surgery
measure: Systemic clinical evaluation
timeFrame: Day 7 after surgery
measure: Systemic clinical evaluation
timeFrame: Day 14 after surgery
measure: Systemic clinical evaluation
timeFrame: Day of surgery
measure: Systemic clinical evaluation
timeFrame: Day 7 after surgery
measure: Systemic clinical evaluation
timeFrame: Day 14 after surgery
measure: Histoarchitecture evaluation
timeFrame: Day of surgery
measure: Histoarchitecture evaluation
timeFrame: Day 14 after surgery
measure: Histoarchitecture evaluation
timeFrame: Day of surgery
measure: Histoarchitecture evaluation
timeFrame: Day 14 after surgery
measure: Immunohistochemistry
timeFrame: Day of surgery
measure: Immunohistochemistry
timeFrame: Day 14 after surgery
measure: Immunohistochemistry
timeFrame: Day of surgery
measure: Immunohistochemistry
timeFrame: Day 14 after surgery
measure: Immunohistochemistry
timeFrame: Day of surgery
measure: Immunohistochemistry
timeFrame: Day 14 after surgery
measure: Immunohistochemistry
timeFrame: Day of surgery
measure: Immunohistochemistry
timeFrame: Day 14 after surgery
measure: Wound healing relative gene expression
timeFrame: Day of surgery
measure: Wound healing relative gene expression
timeFrame: Day 14 after surgery
measure: Wound healing relative gene expression
timeFrame: Day of surgery
measure: Wound healing relative gene expression
timeFrame: Day 14 after surgery
measure: Wound healing relative gene expression
timeFrame: Day of surgery
measure: Wound healing relative gene expression
timeFrame: Day 14 after surgery
measure: Wound healing relative gene expression
timeFrame: Day of surgery
measure: Wound healing relative gene expression
timeFrame: Day 14 after surgery
measure: Wound healing relative gene expression
timeFrame: Day of surgery
measure: Wound healing relative gene expression
timeFrame: Day 14 after surgery
measure: Wound healing relative gene expression
timeFrame: Day of surgery
measure: Wound healing relative gene expression
timeFrame: Day 14 after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
References: