Dermis defects
Conditions
Interventions
Test group:Application of experimental equipment for skin defect repair
Control group:Application of control instruments for skin defect repair
Sponsors
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age = 6 years old and = 65 years old, gender not limited; 2. Patients diagnosed with dermal defects requiring replacement and repair treatment, including: Deep second and third degree burn wounds after scabbing; Trauma, postoperative dermal defects (including fresh wounds after scar resection or release); Granulation wounds; 3.The subjects or their legal guardians are able to understand the purpose of the trial, willing to cooperate with surgical treatment and follow-up, voluntarily participate in the trial, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with total burn area greater than 50% TBSA; 2. Plan to use research products for the replacement and repair of dermal defects with an area of less than 9cm2 or greater than 200cm2; 3. The target wound is a chronic and difficult to heal wound; 4. Target individuals with uncontrolled wound infections; 5. The target wound is a progressive deepening wound, including electric shock injury, radiation injury, and chemical burn injury; 6. The target wound is tendon, nerve vessel or bone exposure; 7. Patients with incomplete wound debridement; 8. The target wound is located on a severely injured limb; 9. Individuals with severe infections throughout the body; 10. Patients with blood system diseases or abnormalities, as well as coagulation dysfunction; 11. Severe liver and kidney dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>3 times the upper limit of normal); Patients with blood creatinine levels greater than 3.0 mg/dL (266 umol/L) or dialysis, as well as severe underlying cardiovascular and cerebrovascular diseases, who require intervention during the trial period; 12. Patients with diabetes; 13. Individuals with collagen allergy constitution; 14. Pregnant or those who plan to conceive during the trial period; 15. Have participated in, are currently participating in, or plan to participate in any other clinical trials of devices or drugs within the past 3 months prior to screening; 16.Other situations that researchers consider unsuitable for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate of skin grafting; | — |
Secondary
| Measure | Time frame |
|---|---|
| VSS scar score;Response rate;Wound healing time;VAS pain score;Equipment usage evaluation; | — |
Countries
China
Contacts
Public ContactShihui Zhu
Shanghai Children's Medical Center A ffiliated to Shanghai Jiao Tong UniversitySchool of Medicine
Outcome results
None listed