Skin Graft
Conditions
Brief summary
Skin graft is a commonly used method in wound repair. The long-term outcome of skin graft is unsatisfied because of the complications of contraction, pigmentation and stiffness. In our preclinical researches, we found that adipose stem cell can improve the texture of grafted skin and reduce contraction. In this trial, we will evaluate the efficiency and safety of autologous adipose stem cells in improving skin graft outcomes.
Interventions
PROCEDUREautologous adipose stem cell injection
Abdominal or buttock fat will be aspirated under local anesthesia or general anesthesia by conventional methods (0.5 ml fat was aspirated per 1 cm2 of skin graft area). The matrix component rich in adipose stem cells will be obtained by chopping, washing and centrifugation. The intervention treatment will be performed after the skin graft sutured. The stem cell components will be injected underneath the skin graft (0.05 ml/cm2).
PROCEDUREsaline injection
saline will be injected underneath skin graft (0.05 ml/cm2).
Sponsors
Shanghai Jiao Tong University School of Medicine
Huaxi Hospital
Ruijin Hospital
Shanghai Zhongshan Hospital
The First Affiliated Hospital of Zhengzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 6-70 years old; 2. Gender: male and female; 3. Scar, surface tumor or soft tissue defect evaluated to be suitable for skin grafting; 4. With two skin grafting areas and the edges more than 4cm apart; 5. Sign informed consent, participate in the study and be able to cooperate with the follow-up.
Exclusion criteria
1. Those who are not suitable for skin grafting; 2. There who are with local lesions in the operation area, such as infection, blood supply disturbance, delayed healing history, decreased soft tissue vitality, history of radiotherapy or going to receive radiotherapy, active ulcer, etc; 3. With severe medical diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerulonephritis, autoimmune diseases, etc.) were complicated; 4. Those who are receiving anticoagulant therapy and cannot suspend treatment; 5. Those who are with abnormal blood routine test, abnormal coagulation function, abnormal cardiac function, abnormal liver function or renal function evaluated by researchers according to the laboratory examination and other clinical signs and symptoms, 6. Those who can't tolerate the operation risk according to the surgeon's evaluation; 7. Pregnant and lactating women; 8. Those who have mental illness, have no insight, can not express and cooperate with each other; 9. Participant in other clinical trials within 30 days before the screen visit of this trial; 10. Those who have not signed the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin elasticity | 6 months | Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin elasticity | 3 months | Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity. |
| Skin color | 3 months | Skin color analyzed by CK Colorimeter CL400. The iTA value is used to evaluate the color of skin graft. |
| POSAS questionnaire of patient | 3 months | POSAS questionnaire of patient. Five questions of pain, itch, thickness, color, stiffness, irregularity. Each question ranks 0, 1, 2. Total score is 0 to 10. |
| POSAS questionnaire of investigator | 3 months | POSAS questionnaire of investigator. Six questions of vascularity, pigmentation, texture, thickness, pliability, surface area. Each question ranks 0, 1, 2. Total score is 0 to 12. |
Contacts
Primary ContactQing-Feng Li
Outcome results
None listed