ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02336997
Recruitment Status : Unknown
Verified April 2016 by Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : January 13, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Scar Procedure: FAT-GRAFT Procedure: SVF-TRANSPLANTATION Procedure: PLACEBO Phase 1 Phase 2

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016

Arm Intervention/treatment
Experimental: FAT-GRAFT
Fat graft transplantation
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.

Experimental: SVF-TRANSPLANTATION
Transplantation of resuspended SVF
Procedure: 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 Comparator: CONTROL
Same volume saline injection
Procedure: PLACEBO
Saline will be injected into expanded skin.




Primary Outcome Measures :
  1. Occurence of Major Adverse Events [ Time Frame: Up to approximately 24 months after study start ]
    Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events

  2. To Measure the Change in Inflation Volume of the Silicone Expander from Baseline at 8 weeks [ Time Frame: baseline and 8 weeks post treatment ]
    Record the inflation volume of each expander with the maintained inner pressure.


Secondary Outcome Measures :
  1. To Measure the Size of Expanded Flap with 3D laser scanner and calculate the surface of expanded skin [ Time Frame: baseline and 8 weeks post treatment ]
    Record the outface of expanded skin flap with 3D laser scanner and calculate the surface of expanded skin

  2. To Measure the Texture of Expanded Flap with VISIA scanner [ Time Frame: 4 weeks and 8 weeks post treatment ]
    Evaluate skin texture with VISIA scanner and compare the characteristics

  3. To Measure Expanded Skin Thickness by Ultrasound Scanning [ Time Frame: baseline, 4 weeks and 8 weeks post treatment ]
    Measure the dermal and epidermal thickness of expanded skin by ultrasound scanning



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336997


Contacts
Contact: Qing-Feng Li, M.D., Ph.D. 00862123271699

Locations
China, Shanghai
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200011
Contact: Qingfeng Li, MD, PhD    0086 21 63089567    liqfliqf@yahoo.com.cn   
Contact: Shuangbai Zhou, MD    0086 13482514585    shuangbaizhou@gmail.com   
Principal Investigator: Qingfeng Li, MD, PhD         
Sub-Investigator: Shuangbai Zhou, MD         
Sub-Investigator: Yun Xie, MD, PhD         
China
Shanghai Ninth People's Hospital Recruiting
Shanghai, China
Contact: Qing-Feng Li, M.D., Ph.D.         
Sponsors and Collaborators
Qing-FengLi Li,MD

Responsible Party: Qing-FengLi Li,MD, Prof., Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02336997     History of Changes
Other Study ID Numbers: [2014]47
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine:
skin regeneration
mechanical stretch