Scar
Conditions
Brief summary
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.
Interventions
PROCEDURECGF injection
CGF injection subdermally to expanded skin at the density of 0.02ml/cm2.
PROCEDUREControl
Saline will be injected into expanded skin
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Measure the Change in Inflation Volume of the Silicone Expander From Baseline at 8 Weeks | baseline and 8 weeks post treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Measure the Texture of Expanded Flap With Canfield's Visia Scanner | baseline and 8 weeks post treatment | Evaluate skin texture with Canfield's Visia skin analysis imaging system and compare the characteristics including RBX red, RBX brown, pores, spots, et al. |
| Occurence of Major Adverse Events | Up to approximately 24 months after study start | Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events |
Countries
China
Outcome results
None listed