A Phase 1/2 interventional study of Fat grafting in Scar and Nevus, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-06-22.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 1/2, Interventional, and Treatment
The purpose of this study is to evaluate whether autologous fat grafting is safe and/or effective to prevent expanded skin from expansion failure.
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.
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Autologous fat graft transplantation subdermally to expanded skin.
Procedure: Fat grafting
Expansion was discontinued until the early signs of complication disappeared.
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.
To Measure the Change in Expansion Volume
Record the volume(ml) of each expander
Time frame: Change from baseline volume at 12 weeks
To Measure the Change in Skin Thickness
Record the thickness of the expanded skin(cm) by ultrasound scanning
Time frame: Change from baseline skin thickness at 12 weeks
To Measure the Texture of Expanded Flap with VISIA scanner
Evaluate skin texture with VISIA scanner and compare the characteristics
Time frame: baseline and 12 weeks post treatment
Occurence of Major Adverse Events
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
Time frame: Up to approximately 12 weeks after study start
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine