One-step Application of Artificial Dermis

Study Overview
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Brief Summary
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The goal of this observational study is to study the effectiveness of one-step application of Lando® artificial dermal regeneration matrix for burn and plastic wound repair. The main question it aims to answer is: the effectiveness of one-step application of Lando® artificial dermal regeneration matrix, including the take rate of skin graft and the appearance recovery of the wound. Participants will be treated with artificial dermis that perfomed with STSG simultaneously. According to the routine clinical practice, the take rate of split-thickness skin graft at about 2-3 weeks and the appearance recovery of the wound at 3 months and 6 months after the implantation were measured.

Official Title
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A Study to Observe the Effect of One-step Application of Artificial Dermis on Burn and Plastic Wounds

Conditions
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Wounds and Injuries

Intervention / Treatment
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* Device: Lando® artificial dermal regeneration matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≤ 70 years old. Patients with non-infectious wounds of deep burns, full-thickness traumatic skin defects or plastic surgery that need to be repaired and reconstructed by artificial dermis. Patients who voluntarily participate in this clinical trial and sign the informed consent form. When the subjects are under 18 years old or they have no capacity or limited capacity, they should have the consent and signature of the guardian or legal representative. Exclusion Criteria: Patients who need to participate in other clinical researchers within 30 days before or during the period of joining the group. Patients with poor control of diabetes (those with fasting blood glucose ≥ 7.0mmol/L or glycosylated hemoglobin HbA1c ≥ 12% after drug control, transaminase > 1.5 times and other diabetic complications). Other cases that researchers believe not suitable for the participants of the trial.

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Participants will be treated with artificial dermis that perfomed with STSG simultaneously. | Device: Lando® artificial dermal regeneration matrix<br>* Participants will be treated with artificial dermis that perfomed with STSG simultaneously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Take rate of skin graft | The percentage of the area of survival skin graft assessed by the Investigator. | 2 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective rate of skin grafting | The rate that the number of cases with excellent or good result divided by the total cases participated. Excellent：take rate of skin graft>90%； Good：take rate of skin graft between 81% and 90%； Fair：take rate of skin graft between 61% and 80%； Poor：take rate of skin graft<60%。 | 2 3 weeks | 
| Vancouver Scar Scale score of skin grafting site | Vancouver Scar Scale score of skin grafting site after 3 months assessed by the Investigator. | 3 months | 
| Vancouver Scar Scale score of skin grafting site | Vancouver Scar Scale score of skin grafting site after 6 months assessed by the Investigator. | 6 months | 
| Vancouver Scar Scale score of donor site | Vancouver Scar Scale score of donor site after 3 months assessed by the Investigator. | 3 months | 
| Vancouver Scar Scale score of donor site | Vancouver Scar Scale score of donor site after 6 months assessed by the Investigator. | 6 months | 
| Percentage of wound contraction | The Percentage that the area of skin grafting area divided by the original area. | 3 months | 
| Percentage of wound contraction | The Percentage that the area of skin grafting area divided by the original area. | 6 months |