Status:
COMPLETED
The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Scar
Nevus
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate whether autologous fat grafting is safe and/or effective to prevent expanded skin from expansion failure.
Detailed Description
The repair of skin defects is a common problem for reconstructive surgeons.Soft tissue expansion is a widely used technique for the repair of skin defects. Early expansion-related complications such a...
Eligibility Criteria
Inclusion
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Implanted silicone expander of 50 to 800 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
- 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;
- Rupture of expanded skin, expander exposure;
- 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 less than 17 or insufficient subcutaneous fat;
- History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
- History of allogenic bone marrow transplantation;
- Pregnant or lactating woman;
- Long history of smoking;
- Evidence of malignant diseases or unwillingness to participate
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02809001
Start Date
January 1 2011
End Date
May 1 2016
Last Update
June 22 2016
Active Locations (1)
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1
Shanghai Ninth People's Hospital
Shanghai, China