Evaluation of the Effect of Autologous Fat and SVF Transplantation in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration
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|ClinicalTrials.gov Identifier: NCT02336997|
Recruitment Status : Unknown
Verified April 2016 by Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : January 13, 2015
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Scar||Procedure: FAT-GRAFT Procedure: SVF-TRANSPLANTATION Procedure: PLACEBO||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2016|
Fat graft transplantation
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.
Transplantation of resuspended SVF
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 Comparator: CONTROL
Same volume saline injection
Saline will be injected into expanded skin.
- Occurence of Major Adverse Events [ Time Frame: 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 [ Time Frame: baseline and 8 weeks post treatment ]Record the inflation volume of each expander with the maintained inner pressure.
- To Measure the Size of Expanded Flap with 3D laser scanner and calculate the surface of expanded skin [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline, 4 weeks and 8 weeks post treatment ]Measure the dermal and epidermal thickness of expanded skin by ultrasound scanning
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336997
|Contact: Qing-Feng Li, M.D., Ph.D.||00862123271699|
|Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200011|
|Contact: Qingfeng Li, MD, PhD 0086 21 63089567 email@example.com|
|Contact: Shuangbai Zhou, MD 0086 13482514585 firstname.lastname@example.org|
|Principal Investigator: Qingfeng Li, MD, PhD|
|Sub-Investigator: Shuangbai Zhou, MD|
|Sub-Investigator: Yun Xie, MD, PhD|
|Shanghai Ninth People's Hospital||Recruiting|
|Contact: Qing-Feng Li, M.D., Ph.D.|