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

NCT ID: NCT02336997

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31

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.

Conditions

Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FAT-GRAFT

Fat graft transplantation

Group Type: EXPERIMENTAL

FAT-GRAFT

Intervention Type: PROCEDURE

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

Transplantation of resuspended SVF

Group Type: EXPERIMENTAL

SVF-TRANSPLANTATION

Intervention Type: PROCEDURE

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.

CONTROL

Same volume saline injection

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: PROCEDURE

Saline will be injected into expanded skin.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

PLACEBO

Saline will be injected into expanded skin.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qing-FengLi Li,MD

OTHER

Sponsor Role: lead

Responsible Party

Qing-FengLi Li,MD

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Shanghai Ninth People's Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Qing-Feng Li, M.D., Ph.D.

Role: CONTACT

00862123271699

Facility Contacts

Qingfeng Li, MD, PhD

Role: primary

liqfliqf@yahoo.com.cn

0086 21 63089567

Shuangbai Zhou, MD

Role: backup

shuangbaizhou@gmail.com

0086 13482514585

Qing-Feng Li, M.D., Ph.D.

Role: primary

Other Identifiers

[2014]47

Identifier Type: -

Identifier Source: org_study_id