Soft tissue defect
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 14-65 years old men and women; 2. Subcutaneous fat disappearance and thinner dermis appeared during the expansion detected by B-type ultrosound 3. Telangiectasia or stretch marks as early expansion complications; or pressure reducing difference is less than 5mmHg compared with the previous injection; 4. Sign informed consent to participate in this study and be able to cooperate with the completion of follow-up.
Exclusion criteria
Exclusion criteria: 1. Potential expansion risks exist in expansion areas, such as infection and, visible vascular embolism and expansion of the skin blood circulation disorders; soft tissue expansion activity decreased (such as the history of radiation or radiotherapy), expansion rupture or ulcer etc.; 2. Expander placed under the muscle or hair area; 3. The patients had abnormal cardiac function, abnormal liver function or abnormal renal function according to the laboratory examination and other clinical signs and symptoms; 4. Drug, stem cells, fat transplant or other intervention therapy was used or performed in 6 months; 5. Severe internal medicine diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerular nephritis, blood system diseases, autoimmune diseases, malignant tumors, etc.); 6. Under anticoagulant therapy or long-term use of blood circulation and anti drug discontinuation of health products in January; 7. With long history of smoking and 3 months had smokers; 8. Pregnant women and lactating women; 9. With mental disease, no insight, can not be exact expression and cooperation; 10. Participated in other clinical trials within 60 days before the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expansion Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Expanded skin area;Thickness of expanded skin;Texture of expanded skin;Contracture rate of flap; | — |
Countries
China
Contacts
Shanghai Ninth People's Hospital, Shanghai Jiaotong UNiversity School of Medicine