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

Phase 1

• Conditions: Scar
• Interventions: Procedure: PLACEBO; Procedure: FAT-GRAFT; Procedure: SVF-TRANSPLANTATION

• Registration Number: NCT02336997
• Lead Sponsor: Qing-FengLi Li,MD

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.

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 Timeline

• Study First Submitted: 2014-12-26
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-13
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL	PLACEBO	Same volume saline injection
FAT-GRAFT	FAT-GRAFT	Fat graft transplantation
SVF-TRANSPLANTATION	SVF-TRANSPLANTATION	Transplantation of resuspended SVF

Primary Outcome Measures

Name	Time	Method
To Measure the Change in Inflation Volume of the Silicone Expander from Baseline at 8 weeks	baseline and 8 weeks post treatment	Record the inflation volume of each expander with the maintained inner pressure.
Occurence of Major Adverse Events	Up to approximately 24 months after study start	Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events

Secondary Outcome Measures

Name	Time	Method
To Measure the Texture of Expanded Flap with VISIA scanner	4 weeks and 8 weeks post treatment	Evaluate skin texture with VISIA scanner and compare the characteristics
To Measure Expanded Skin Thickness by Ultrasound Scanning	baseline, 4 weeks and 8 weeks post treatment	Measure the dermal and epidermal thickness of expanded skin by ultrasound scanning
To Measure the Size of Expanded Flap with 3D laser scanner and calculate the surface of expanded skin	baseline and 8 weeks post treatment	Record the outface of expanded skin flap with 3D laser scanner and calculate the surface of expanded skin

Trial Locations

Locations (2)

Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, China

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China