Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
37 participants
OBSERVATIONAL
2021-01-28
2022-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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1
Participants will be treated with artificial dermis that perfomed with STSG simultaneously.
Lando® artificial dermal regeneration matrix
Participants will be treated with artificial dermis that perfomed with STSG simultaneously.
Interventions
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Lando® artificial dermal regeneration matrix
Participants will be treated with artificial dermis that perfomed with STSG simultaneously.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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
2. 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).
3. Other cases that researchers believe not suitable for the participants of the trial.
70 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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NFEC-2021-033
Identifier Type: -
Identifier Source: org_study_id