Chronic Wound Clinical Trial
Official title:
Clinical Trial for the Efficacy and Safety of Paste Type Acellular Dermal Matrix in Chronic Wound Healing
NCT number | NCT04019639 |
Other study ID # | 2017-02 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 5, 2017 |
Est. completion date | July 31, 2020 |
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | July 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul | Jongno-gu |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Hanyang University, Korea Health Industry Development Institute, St. Vincent's Hospital-Manhattan |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Complete healing rate | Complete healing rate after 12 weeks of medical device application * Definition of complete healing: A complete healing is defined as a state in which the skin is completely reepithelialized and the skin is completely closed. Additional operations such as skin grafting, flap surgery, primary suture, etc. are not performed. (definition of complete healing: |
12 weeks | |
Secondary | Period of time to complete healing | Period of time from medical device application to complete healing * Definition of complete healing: A complete healing is defined as a state in which the skin is completely reepithelialized and the skin is completely closed. Additional operations such as skin grafting, flap surgery, primary suture, etc. are not performed. |
The period to complete healing(through study completion, an average of 12 weeks) | |
Secondary | Step of granulation tissue | Step for 12weeks of granulation tissue (The steps of granulation tissues are visualized by the following criteria, and the steps are recorded separately from A-E) A: Skin intact or partial thickness wound B: Bright, beefy red; 75% to 100% of wound filled & or tissue overgrowth C: right, beefy red; < 75% & > 25% of wound filled D: Pink, &/or dull, dusky red & or fills = 25% of wound E: No granulation tissue present |
12 weeks | |
Secondary | The time it took to reach granulation tissue formation | The period of time required for granulation tissue formation to reach 100% | The period of time required for granulation tissue formation to reach 100% (through study completion, an average of 12 weeks) | |
Secondary | Level of tissue exposed after 12 weeks of medical device application | After 12 weeks of medical device application, the level of exposed tissue is divided into partial thickness skin, full thickness skin, subcutaneous, deep fascia, muscle, tendon, bone, and joint, and the distribution is compared. | 12 weeks |
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