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| Name | Class |
|---|---|
| Huaxi Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell group | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous adipose stem cell injection | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Skin elasticity | Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Skin elasticity | Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity. | 3 months |
| Skin elasticity | Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing-Feng Li | Contact | +862123271699 | shuangbaizhou@yahoo.com |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| OTHER |
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| saline injection | Procedure | saline will be injected underneath skin graft (0.05 ml/cm2). |
|
| 12 months |
| Skin color | Skin color analyzed by CK Colorimeter CL400. The iTA value is used to evaluate the color of skin graft. | 3 months |
| Skin color | Skin color analyzed by CK Colorimeter CL400. The iTA value is used to evaluate the color of skin graft. | 6 months |
| Skin color | Skin color analyzed by CK Colorimeter CL400. The iTA value is used to evaluate the color of skin graft. | 12 months |
| POSAS questionnaire of patient | 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. | 3 months |
| POSAS questionnaire of patient | 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. | 6 months |
| POSAS questionnaire of patient | 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. | 12 months |
| POSAS questionnaire of investigator | 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. | 3 months |
| POSAS questionnaire of investigator | 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. | 6 months |
| POSAS questionnaire of investigator | 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. | 12 months |
| D017670 |
| Sodium Compounds |