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The purpose of this study is to evaluating whether autologous Concentrate Growth Factors(CGF) is safe and/or effective to accelerating skin regeneration and soft tissue expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGF injection group | Experimental | Concentrate Growth Factors(CGF) will be harvested through centrifugation afte intravenous blood collection. Venous blood was collected in tube and then centrifuged in Medifuge system(Thermo Scientific). About 2ml liquid CGF can be harvested from 9ml venous blood. Patients will receive autologous CGF injection subdermally to expanded skin at the density of 0.02 ml/cm2. |
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| Control group | Sham Comparator | 0.9% saline will be injected into expanded skin for control study. Patients will receive saline injection subdermally to expanded skin at the density of 0.02 ml/cm2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGF injection | Procedure | CGF injection subdermally to expanded skin at the density of 0.02ml/cm2. |
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| Measure | Description | Time Frame |
|---|---|---|
| To Measure the Change in Inflation Volume of the Silicone Expander From Baseline at 8 Weeks | Record the inflation volume(ml) of each expander with the maintained inner pressure. The inflation volume was recorded according to the injection volume during expansion. | baseline and 8 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To Measure the Texture of Expanded Flap With Canfield's Visia Scanner | Evaluate skin texture with Canfield's Visia skin analysis imaging system and compare the characteristics including RBX red, RBX brown, pores, spots, et al. | baseline and 8 weeks post treatment |
| Occurence of Major Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
• Not fit for soft tissue expansion treatment;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Control | Procedure | Saline will be injected into expanded skin |
|
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events |
| Up to approximately 24 months after study start |
| Shanghai Ninth People's Hospital | Recruiting | Shanghai | China |
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