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

NCT03406143 | Unknown

• 1 other identifier: CGFskin
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Scar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To Measure the Texture of Expanded Flap With Canfield's Visia Scanner

  baseline and 8 weeks post treatment

• Occurence of Major Adverse Events

  Up to approximately 24 months after study start

Study Arms (2)

CGF injection group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

CGF injection PROCEDURE

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

CGF injection group

Control PROCEDURE

Saline will be injected into expanded skin

Control group

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (2)

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

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Shanghai Ninth People's Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.,Head of PRS Department

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 23, 2018
• Study Start: September 1, 2016
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

CN (2)