Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration
NCT ID: NCT03406143
Last Updated: 2018-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
26 participants
INTERVENTIONAL
2016-09-01
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CGF injection group
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.
CGF injection
CGF injection subdermally to expanded skin at the density of 0.02ml/cm2.
Control group
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.
Control
Saline will be injected into expanded skin
Interventions
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CGF injection
CGF injection subdermally to expanded skin at the density of 0.02ml/cm2.
Control
Saline will be injected into expanded skin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
14 Years
65 Years
ALL
Yes
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Qing-FengLi Li,MD
M.D., Ph.D.,Head of PRS Department
Locations
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Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Ninth People's Hospital
Shanghai, , China
Countries
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Facility Contacts
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Qing-Feng Li, M.D., Ph.D.
Role: primary
Other Identifiers
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CGFskin
Identifier Type: -
Identifier Source: org_study_id
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