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

Not Applicable

• Conditions: Scar
• Interventions: Procedure: Control; Procedure: CGF injection

• Registration Number: NCT03406143
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-12-19
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-12
• Last Update Submitted: 2018-01-12
• Study First Posted: 2018-01-23
• Last Update Posted: 2018-01-23
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control	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.
CGF injection group	CGF injection	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, China