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

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03406143
• Other study ID #: CGFskin
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2017
• Last updated: January 12, 2018
• Start date: September 1, 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: January 2018
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scar

Intervention

Procedure:
• CGF injection
CGF injection subdermally to expanded skin at the density of 0.02ml/cm2.
• Control
Saline will be injected into expanded skin

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai
China	Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Measure the Change in Inflation Volume of the Silicone Expander From Baseline at 8 Weeks	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.	baseline and 8 weeks post treatment
Secondary	To Measure the Texture of Expanded Flap With Canfield's Visia Scanner	Evaluate skin texture with Canfield's Visia skin analysis imaging system and compare the characteristics including RBX red, RBX brown, pores, spots, et al.	baseline and 8 weeks post treatment
Secondary	Occurence of Major Adverse Events	Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events	Up to approximately 24 months after study start