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

NCT04019639 | Unknown

• 1 other identifier: 2017-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Wound

Keywords

ADM; acellular dermal matrix

Outcome Measures

Primary Outcomes (1)

• wound reduction rate

  At 12 weeks after the application of the medical device, the wound reduction At 12 weeks after the application of the medical device, the wound reduction rate

  12 weeks

Secondary Outcomes (5)

• Complete healing rate

  12 weeks

• Period of time to complete healing

  The period to complete healing(through study completion, an average of 12 weeks)

• Step of granulation tissue

  12 weeks

• The time it took to reach granulation tissue formation

  The period of time required for granulation tissue formation to reach 100% (through study completion, an average of 12 weeks)

• Level of tissue exposed after 12 weeks of medical device application

  12 weeks

Study Arms (2)

CG Paste+EasyFoam

EXPERIMENTAL

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.

Device: application of CG Paste+EasyFoam

EasyFoam

ACTIVE COMPARATOR

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.

Device: application of EasyFoam

Interventions

application of CG Paste+EasyFoam 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.

CG Paste+EasyFoam

application of EasyFoam 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.

EasyFoam

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Korea Health Industry Development Institute: collaborator
• Hanyang University: collaborator
• St Vincent's Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

Study Officials

• Sang Wha Kim, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Youn Hwan Kim, Ph.D

  Hanyang University

  PRINCIPAL INVESTIGATOR

• Hyung Sup Shim, Ph.D

  St Vincent's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Wha Kim, Ph.D

CONTACT

82-2-2072-2374; sw1215@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: July 15, 2019
• Study Start: April 5, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

KR (1)