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

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

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 Overview

• Status: Unknown
• Conditions: Scar
• Intervention / Treatment: Procedure: CGF injection; Procedure: Control

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Ninth People's Hospital
    • Contact: Qing-Feng Li, M.D., Ph.D.; Phone Number: 86 21 23271699
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Recruiting
      • Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Li Qing Feng, MD; PhD; Phone Number: 0086 21 63089567; Email: dr.liqingfeng@yahoo.com
      • Principal Investigator: Li Qingfeng, MD, PhD
      • Sub-Investigator: Xie Yun, MD
      • Sub-Investigator: Cheng chen, MD
      • Contact: Chen Cheng, MD; Phone Number: 0086 21 13621925833; Email: shno9hospital@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGF injection group; 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.	Procedure: CGF injection; CGF injection subdermally to expanded skin at the density of 0.02ml/cm2.
Sham Comparator: Control group; 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.	Procedure: Control; Saline will be injected into expanded skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): August 31, 2019
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CGFskin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No