Full-thickness skin defect wounds of extremities requiring plastic surgery due to scar contracture, acute defect, congenital deformity, birthmark and giant mole excision
Conditions
Interventions
Queue one:Receive simultaneous transplantation of double-layer artificial dermal repair material combined with autologous thin skin
Queue two:Receive an autologous full-thickness skin graft
Sponsors
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who voluntarily participate in this clinical study and sign the informed consent; 2. Commit to abide by the research procedures and cooperate with the implementation of the whole process of research; 3. Plastic wounds that need to be transplanted with dermal matrix; 4. Conform to specific laboratory test results; 5. Be able to adhere to and cooperate with surgical treatment and follow-up throughout the later period; 6. If it is a child-bearing woman, she should use contraception for at least one month before the screening, and promise to take contraception throughout the study period and continue to the specified time after the end of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects whose infection has not been controlled after debridement and treatment of the wound; 2. The pathological diagnosis of the wound surface is suspected or confirmed to be malignant tumor; 3. Malignant tumor research subjects, or those who need to receive radiotherapy and chemotherapy during the research period; 4. Subjects with poorly controlled diabetes (fasting blood glucose is still >=7.0mmol/L after drug control, or glycated hemoglobin HbA1c >=12%, and transaminase> 1.5 times the upper limit of the normal value and other diabetic complications); 5. Those with severe heart, liver, kidney and other organ or system dysfunction that cannot tolerate surgery; 6. Subjects allergic to bovine collagen and chondroitin sulfate; 7. Other researchers think that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin graft survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| One-time survival rate of skin grafting;Wound shrinkage rate;Vancouver Scar Scale after Wound Surgery;Functional evaluation of joint range of motion in the skin graft area;Evaluation of qualitative recovery of skin graft area function; | — |
Countries
China
Contacts
Public ContactLiu Yan
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Outcome results
None listed