Status:
UNKNOWN
Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Scar
Eligibility:
All Genders
14-65 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- • 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.
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2019
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03406143
Start Date
September 1 2016
End Date
August 31 2019
Last Update
January 23 2018
Active Locations (2)
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1
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
2
Shanghai Ninth People's Hospital
Shanghai, China