Patients with skin and soft tissue defects
Conditions
Interventions
experimental group:Skin soft tissue amplification was used to seal the wound
control group:skin grafts
Sponsors
Shanghai Changhai Hospital Burn Department
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years; 2. Patients who are diagnosed with skin and soft tissue defects caused by various reasons such as burns, trauma, pressure ulcers and scar resection and need skin grafting or skin flap transfer; 3. The diagnostic criteria for burns refer to the diagnostic criteria of Burn Surgery (Second Edition); 4. The wound or skin and soft tissue defects are located on the limbs or trunk. The width of the wound margin on both sides of the wound on both upper extremities is 3-6cm, and the width of the wound on both sides of the wound on both lower limbs, trunk and buttocks is between 3-10cm. Upright axial) between 3-20cm; 5. The distance between the wound and other wound edges is at least 5cm; 6. There is no obvious infection on the wound surface, and there is no obvious necrotic tissue after thorough debridement; 7. According to GCP regulations, obtain informed consent and voluntarily sign the informed consent form, and volunteer to be tested.
Exclusion criteria
Exclusion criteria: 1. Patients with severe lymphedema, coagulation disorders, autoimmune diseases, cardiovascular and cerebrovascular diseases, severe liver, lung and kidney diseases, and diabetic patients with poor blood sugar control (check HBA1c>8% within one week); 2. The total burn area is greater than 30% TBSA; 3. Severe burns or trauma patients are life-threatening, and the limbs may be at risk of necrosis and amputation; 4. The researchers believe that there are factors affecting wound healing, such as the use of corticosteroids, immunosuppressive drugs and other drugs, and received chemotherapy or radiotherapy within 1 year; 5. Receive or plan to receive drugs or treatments that the investigator believes will interfere with or affect the speed and quality of wound healing; 6. Have participated in or are participating in other clinical investigators within 30 days before screening; 7. Women who are pregnant, pregnant or breastfeeding; 8. Skin and soft tissue augmentation techniques are not suitable for other reasons such as cross-joint sites or poor systemic conditions; 9. Other researchers think that they are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean wound healing time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total wound closure rate;Wound healing quality;treatment expense;length of stay; | — |
Countries
China
Contacts
Public ContactJi Shizhao
Changhai hospital
Outcome results
None listed