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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03406143
Other study ID # CGFskin
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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