Chronic Wound Clinical Trial
Official title:
Clinical Trial for the Efficacy and Safety of Paste Type Acellular Dermal Matrix in Chronic Wound Healing
The purpose of this study is to evaluate the efficacy and safety of wound sizing and completeness in chronic window treatment, and to confirm the superiority of area reduction in CG Paste and form-dressing as compared to form-dressing alone groups and CG Paste and form-dressing companion groups.
wound refers to a condition in which the skin is damaged by a cause. In general, open wound
rather than closed wound requires active treatment. It is important to make sure that the
wound are cured early and through proper treatment. If the wound is open for a long time,
secondary complications such as infection can occur and are easy to transition to chronic
wound. Chronic wound refers to an idea that does not heal after a period of time after a
normal wound healing process, which is usually defined as if it does not heal for more than
three to four weeks. 1. These chronic wound include diabetic foot ulcer, pressure ulcer,
vascular ulcer, etc. In addition, with the recent aging of the population, the proportion of
elderly patients increases, and the proportion of chronic wound where even simple surgical
wound does not heal normally, resulting in increased expenditure on health care and decreased
quality of life for patients.
Biotechnical dermal transplantation material, including acellular dermal matrix, are known to
be more effective in wound healing than conventional wound treatments.
The mechanism of action of acellular matrices including acellular dermal matrix, is as
follows: 1) it functions as a support for cell growth and granulation tissue formation, 2)
has receptors capable of attaching to fibroblasts, 3) induction of angiogenesis, 4)
chemoattractant activity of vascular endothelial cells, 5) role of providing various growth
factors, and temporary storage function.
Unlike other products generally known as CG paste, the acellular allo-dermal matrix product
to be used in this study is made into a paste type for ease of use after freeze-drying and
granulation process after undergoing the process of degreasing of the same kind of dermis .
Conventional sheet-type products can not be applied to curved wounds, they must be cut and
rehydrated during use, while CG paste is easy to apply to curved wounds and can be applied
directly to the desired wound area without rehydration It is expected to be a ready-to-use
product with similar clinical effects to existing acellular allo-dermal matrix.
The purpose of this study is to evaluate the efficacy and safety of wound sizing and
completeness in chronic window treatment, and to confirm the superiority of area reduction in
CG Paste and form-dressing as compared to form-dressing alone groups and CG Paste and
form-dressing companion groups.
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