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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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.
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.
Saline will be injected into expanded skin.
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Ninth People's Hospital
Shanghai, China
RECRUITINGOccurence of Major Adverse Events
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
Time frame: 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.
Time frame: baseline and 8 weeks post treatment
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
Time frame: 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
Time frame: 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
Time frame: baseline, 4 weeks and 8 weeks post treatment
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