Clinical trial for the efficacy and safety of paste type acellular dermal matrix in chronic wound healing.
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0003027
- Lead Sponsor
- Hanyang University Seoul Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
adults over 19 years
- Dermal defect from skin defect in Full-thickness skin to bone exposure level after debriment in wound area
- chronic wounds that have not been healed despite adequate treatment for more than 3 weeks after wounds
- At the time of the study, patients with a wound size of 4 cm2 or more
- Patients with superficial or partial thickness skin defect
- Patient with osteomyelitis
- Undermining wound, tunneling wound which can not measure the exact depth (can participate if open wound due to debriment)
- Patients who exceeded 12% of HbA1C within 3 months before participating in the study
- Patients with a serum creatinine concentration of 3.0 mg/dL or more within 30 days before participating in 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 wound infections (available after infection treatment)
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method At the start of treatment by each group Wound size reduction rate(%) after 12 weeks compared to wound size
- Secondary Outcome Measures
Name Time Method wound closure rate;The period to complete wound closure;The changes in the level of tissue exposed (divided into partial thickness skin, full thickness skin, subQ, deep fascia, muscle, tendon, bone);adverse events