Efficacy of Paste Type Acellular Dermal Matrix(CG Paste) in Chronic Wound Healing

NCT ID: NCT04019639

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-05
• Study Completion Date: 2020-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Chronic Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CG Paste+EasyFoam

The subjects assigned to the test group through random assignment will receive the wound treatment by applying CG Paste and EasyFoam. CG Paste is a medical device currently marketed in CGBio.It is a free-flowing, acellular allogeneic dermis processed from human tissue skin, and then granulated and homogenized. This increases the water content and viscosity of the micronized ADM particles mixed with the gelatin sol carrier to protect the wound area and maintain the wet environment by applying to the desired wound area.It contains collagen, elastin and various growth factors in the dermis and has excellent tissue compatibility compared to the heterogeneous or synthetic material, so that the immune rejection is hardly observed in the graft site.

It also contains collagen, elastin, fibronectin, laminin, and proteoglycans, which are components of the human skin, to help the interaction between normal cells and extracellular matrix.

Group Type: EXPERIMENTAL

application of CG Paste+EasyFoam

Intervention Type: DEVICE

Prior to application of CG paste, sharp debridement can be performed first in the operating room under local anesthesia or general anesthesia. After this, hemostasis is performed by an electrocoagulator and the medical device is applied to the affected area. During the procedure, remove the packaging material and remove the syringe to remove the protective cap in front of the syringe. Slowly push the syringe plunger and apply the contents to the area where you want to use. Depending on the location and size of the wound area, an injection cap can be used. Apply CG paste and apply Easyfoam to finish the dressing.

EasyFoam

Subjects randomly assigned to the control group receive EasyFoam treatment for wound healing.

The foam has excellent moisture permeability, absorbs a large amount of exudates, and prevents scar formation to minimize scar formation.

Group Type: ACTIVE_COMPARATOR

application of EasyFoam

Intervention Type: DEVICE

Prior to applying EasyFoam, sharp debridement can be performed first in the operating room under local anesthesia or general anesthesia. Marginal resection is performed until the necrotic tissue is removed sufficiently and pin point bleeding is seen on the wound. After that, hemostasis is done with an electrocoagulator and EasyFoam is applied to the affected area.

Interventions

application of CG Paste+EasyFoam

Prior to application of CG paste, sharp debridement can be performed first in the operating room under local anesthesia or general anesthesia. After this, hemostasis is performed by an electrocoagulator and the medical device is applied to the affected area. During the procedure, remove the packaging material and remove the syringe to remove the protective cap in front of the syringe. Slowly push the syringe plunger and apply the contents to the area where you want to use. Depending on the location and size of the wound area, an injection cap can be used. Apply CG paste and apply Easyfoam to finish the dressing.

Intervention Type: DEVICE

application of EasyFoam

Prior to applying EasyFoam, sharp debridement can be performed first in the operating room under local anesthesia or general anesthesia. Marginal resection is performed until the necrotic tissue is removed sufficiently and pin point bleeding is seen on the wound. After that, hemostasis is done with an electrocoagulator and EasyFoam is applied to the affected area.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults over 19 years
• Patients with skin defect from full-thickness skin defect to bone exposure level after debridement of wound
• Chronic wounds that have not been healed despite adequate treatment for more than 3 weeks after wounding
• At the time of the study, patients with a wound size of 4 cm 2 or more

Exclusion Criteria

• Patients with superficial or partial thickness skin defect
• osteomyelitis patient
• An undermining wound, tunneling wound, which can not measure the exact depth, can be used if the wound is open wound due to debridement of wound.
• Patients who exceeded 12% of HbA1c within 3 months before participating in the study
• Patients with serum creatinine concentration of 3.0 mg / dL or more within 30 days before the study
• Patients who have applied other medical devices and growth factors for wound healing within 30 days before participating in the study
• Patients with lesion infections (available after infection treatment)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role: collaborator

Hanyang University

OTHER

Sponsor Role: collaborator

St Vincent's Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Wha Kim

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Wha Kim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Youn Hwan Kim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Hyung Sup Shim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

St Vincent's Hospital

Locations

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang Wha Kim, Ph.D

Role: CONTACT

sw1215@snu.ac.kr

82-2-2072-2374

Facility Contacts

Sang Wha Kim, Ph.D

Role: primary

sw1215@snu.ac.kr

82-2-2072-2374

Other Identifiers

2017-02

Identifier Type: -

Identifier Source: org_study_id