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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Fat grafting | Experimental | Autologous fat graft transplantation subdermally to expanded skin. |
|
| Control | No Intervention | Expansion was discontinued until the early signs of complication disappeared. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fat grafting | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To Measure the Change in Expansion Volume | Record the volume(ml) of each expander | 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 | Change from baseline skin thickness at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To Measure the Texture of Expanded Flap with VISIA scanner | Evaluate skin texture with VISIA scanner and compare the characteristics | baseline and 12 weeks post treatment |
| Occurence of Major Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D009506 | Nevus |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018326 | Nevi and Melanomas |
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Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
| Up to approximately 12 weeks after study start |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |