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

Shanghai Jiao Tong University School of Medicine26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Scar

Interventions

CGF injectionPROCEDURE

CGF injection subdermally to expanded skin at the density of 0.02ml/cm2.

ControlPROCEDURE

Saline will be injected into expanded skin

Eligibility

Sex: ALLMin age: 14 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Ninth People's Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: baseline and 8 weeks post treatment

Secondary Outcomes

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.

Time frame: baseline and 8 weeks post treatment

Occurence of Major Adverse Events

Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events

Time frame: Up to approximately 24 months after study start

Data from ClinicalTrials.gov

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