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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Participants will be treated with artificial dermis that perfomed with STSG simultaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lando® artificial dermal regeneration matrix | Device | Participants will be treated with artificial dermis that perfomed with STSG simultaneously. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with non-infectious wounds of deep burns, full-thickness traumatic skin defects or plastic surgery that require repair and reconstruction of dermal defects.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
We are sorry to declaim that the individual participant data is in a state of confidentiality.
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 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 |