Evaluation of the Effect of Autologous Fat and SVF Transplantation in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration

Scar Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02336997
• Other study ID #: [2014]47
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 26, 2014
• Last updated: April 18, 2016
• Start date: January 2015

Study information

• Verified date: April 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Qing-Feng Li, M.D., Ph.D.
• Phone: 00862123271699
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluating whether autologous grafted fat transplantation or SVF transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.

Description:

Reconstruction of large scale skin defect is a challenge to clinical surgeons. Soft tissue expansion has won wide attention in recent years as it promotes skin regeneration with perfectly matched tissue. However, some patients with poor skin regenerative ability would suffer from skin flap over-thinned and even necrosis under the continuous stretching by silicone expander. This study is to evaluate the effects of autologous fat graft/SVF transplantation on accelerating skin regeneration and promoting tissue expansion process.

Patients aged between 18 to 60 years old who appear with deteriorated expanded skin will be enrolled and randomized into three groups, named as the experimental group and the control group. Patients from the FAT-GRAFT group will have a liposuction and subdermal fat graft transplantation. Patients from the SVF-TRANSPLANTATION group will have a liposuction and SVF will be separated and transplanted intradermally to expanded skin. Patients from the control group will have saline injection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Inclusion Criteria:

• Age of 18 to 60 years;

• Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;

• Implanted silicone expander of 80 to 600 ml in size;

• History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scar

Intervention

Procedure:
• FAT-GRAFT
Liposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin at the density of 0.1 ml/cm2.
• SVF-TRANSPLANTATION
Liposuction will be performed. SVF will be separated from autologous fat graft by collagenase digestion. Patients will receive resuspended SVF transplantation subdermally to expanded skin at the density of 1*10e6 cells/cm2.
• PLACEBO
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
Qing-FengLi Li,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	To Measure the Change in Inflation Volume of the Silicone Expander from Baseline at 8 weeks	Record the inflation volume of each expander with the maintained inner pressure.	baseline and 8 weeks post treatment	No
Secondary	To Measure the Size of Expanded Flap with 3D laser scanner and calculate the surface of expanded skin	Record the outface of expanded skin flap with 3D laser scanner and calculate the surface of expanded skin	baseline and 8 weeks post treatment	No
Secondary	To Measure the Texture of Expanded Flap with VISIA scanner	Evaluate skin texture with VISIA scanner and compare the characteristics	4 weeks and 8 weeks post treatment	No
Secondary	To Measure Expanded Skin Thickness by Ultrasound Scanning	Measure the dermal and epidermal thickness of expanded skin by ultrasound scanning	baseline, 4 weeks and 8 weeks post treatment	No