Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin

Conditions
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Scar

Intervention / Treatment
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* Procedure: CGF injection
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 14 to 65 years; Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back; Persistent high level of expander internal pressure; Need for further skin expansion; Exclusion Criteria: • Not fit for soft tissue expansion treatment; Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy; Significant renal, cardiovascular, hepatic and psychiatric diseases; Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV) BMI >30; History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis; History of allogenic bone marrow transplantation; Long history of smoking; Evidence of malignant diseases or unwillingness to participate.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGF injection group<br>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. | Procedure: CGF injection<br>* CGF injection subdermally to expanded skin at the density of 0.02ml/cm2.<br>|
| Sham Comparator: Control group<br>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. | Procedure: Control<br>* Saline will be injected into expanded skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events | Up to approximately 24 months after study start |