Scar
Conditions
Keywords
skin regeneration, mechanical stretch
Brief summary
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
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.
Interventions
PROCEDUREFAT-GRAFT
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.
PROCEDURESVF-TRANSPLANTATION
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.
PROCEDUREPLACEBO
Saline will be injected into expanded skin.
Sponsors
Qing-FengLi Li,MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of Major Adverse Events | Up to approximately 24 months after study start | Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events |
| To Measure the Change in Inflation Volume of the Silicone Expander from Baseline at 8 weeks | baseline and 8 weeks post treatment | Record the inflation volume of each expander with the maintained inner pressure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Measure the Size of Expanded Flap with 3D laser scanner and calculate the surface of expanded skin | baseline and 8 weeks post treatment | Record the outface of expanded skin flap with 3D laser scanner and calculate the surface of expanded skin |
| To Measure the Texture of Expanded Flap with VISIA scanner | 4 weeks and 8 weeks post treatment | Evaluate skin texture with VISIA scanner and compare the characteristics |
| To Measure Expanded Skin Thickness by Ultrasound Scanning | baseline, 4 weeks and 8 weeks post treatment | Measure the dermal and epidermal thickness of expanded skin by ultrasound scanning |
Countries
China
Contacts
Primary ContactQing-Feng Li, M.D., Ph.D.
Outcome results
None listed