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

Shanghai Jiao Tong University School of Medicine

Status: Unknown

Conditions: Scar

Treatments: Procedure: CGF injection; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03406143

CGFskin

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups

CGF injection group

Experimental group

Description:

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.

Treatment:

Procedure: CGF injection

Control group

Sham Comparator group

Description:

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.

Treatment:

Procedure: Control