Shanghai Ninth People's Hospital
Shanghai, China
NCT Number: NCT02809001
The purpose of this study is to evaluate whether autologous fat grafting is safe and/or effective to prevent expanded skin from expansion failure.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1 / Phase 2
Shanghai, China
The repair of skin defects is a common problem for reconstructive surgeons.Soft tissue expansion is a widely used technique for the repair of skin defects. Early expansion-related complications such as skin thinning, telangiectasia, and striae may result in expansion failure and ultimately jeopardize final outcome. In the past years, discontinuation of the expansion procedure was the only therapeutic option, when early alarm signs such as semitransparent appearance and telangiectasia of the expanded skin were encountered. We aimed to overcome these complications by therapeutic fat grafting to prevent skin necrosis and enable continuation of the expansion procedure.
Patients undergoing soft tissue expansion treatment for resurfacing skin lesions including scars and nevi that required therapeutic intervention due to early complication signs were included in this study. Patients were randomly divided into treatment group using autologous fat grafting and control group with discontinued expansion and expectant management. The treatment group received autologous fat transfer to the expanded skin.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the experimental group, 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.
Time frame: Change from baseline volume at 12 weeks
Record the volume(ml) of each expander
Time frame: Change from baseline skin thickness at 12 weeks
Record the thickness of the expanded skin(cm) by ultrasound scanning
Time frame: baseline and 12 weeks post treatment
Evaluate skin texture with VISIA scanner and compare the characteristics
Time frame: Up to approximately 12 weeks after study start
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
Shanghai Jiao Tong University School of Medicine
Other
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