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The purpose of this study is to evaluating whether autologous grafted fat transplantation or SVF transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.
Reconstruction of large scale skin defect is a challenge to clinical surgeons. Soft tissue expansion has won wide attention in recent years as it promotes skin regeneration with perfectly matched tissue. However, some patients with poor skin regenerative ability would suffer from skin flap over-thinned and even necrosis under the continuous stretching by silicone expander. This study is to evaluate the effects of autologous fat graft/SVF transplantation on accelerating skin regeneration and promoting tissue expansion process.
Patients aged between 18 to 60 years old who appear with deteriorated expanded skin will be enrolled and randomized into three groups, named as the experimental group and the control group. Patients from the FAT-GRAFT group will have a liposuction and subdermal fat graft transplantation. Patients from the SVF-TRANSPLANTATION group will have a liposuction and SVF will be separated and transplanted intradermally to expanded skin. Patients from the control group will have saline injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAT-GRAFT | Experimental | Fat graft transplantation |
|
| SVF-TRANSPLANTATION | Experimental | Transplantation of resuspended SVF |
|
| CONTROL | Placebo Comparator | Same volume saline injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAT-GRAFT | Procedure | Liposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin at the density of 0.1 ml/cm2. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of Major Adverse Events | Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events | Up to approximately 24 months after study start |
| To Measure the Change in Inflation Volume of the Silicone Expander from Baseline at 8 weeks | Record the inflation volume of each expander with the maintained inner pressure. | baseline and 8 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To Measure the Size of Expanded Flap with 3D laser scanner and calculate the surface of expanded skin | Record the outface of expanded skin flap with 3D laser scanner and calculate the surface of expanded skin | baseline and 8 weeks post treatment |
| To Measure the Texture of Expanded Flap with VISIA scanner |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing-Feng Li, M.D., Ph.D. | Contact | 00862123271699 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| SVF-TRANSPLANTATION | Procedure | Liposuction will be performed. SVF will be separated from autologous fat graft by collagenase digestion. Patients will receive resuspended SVF transplantation subdermally to expanded skin at the density of 1*10e6 cells/cm2. |
|
| PLACEBO | Procedure | Saline will be injected into expanded skin. |
|
Evaluate skin texture with VISIA scanner and compare the characteristics |
| 4 weeks and 8 weeks post treatment |
| To Measure Expanded Skin Thickness by Ultrasound Scanning | Measure the dermal and epidermal thickness of expanded skin by ultrasound scanning | baseline, 4 weeks and 8 weeks post treatment |
| Shanghai Ninth People's Hospital | Recruiting | Shanghai | China |
|