Evaluation of the Effect of Autologous Fat and SVF Transplantation in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Scar

Intervention / Treatment
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* Procedure: FAT-GRAFT
* Procedure: SVF-TRANSPLANTATION
* Procedure: PLACEBO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: Age of 18 to 60 years; Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back; Implanted silicone expander of 80 to 600 ml in size; History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks; Persistent high level of expander internal pressure; Need for further skin expansion; Exclusion Criteria: Not fit for soft tissue expansion treatment; Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy; Significant renal, cardiovascular, hepatic and psychiatric diseases; Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV) BMI >30; History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis; History of allogenic bone marrow transplantation; Long history of smoking; Evidence of malignant diseases or unwillingness to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAT-GRAFT<br>Fat graft transplantation | Procedure: FAT-GRAFT<br>* 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.<br>|
| Experimental: SVF-TRANSPLANTATION<br>Transplantation of resuspended SVF | Procedure: SVF-TRANSPLANTATION<br>* 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.<br>|
| Placebo Comparator: CONTROL<br>Same volume saline injection | Procedure: PLACEBO<br>* Saline will be injected into expanded skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin regeneration, mechanical stretch