Clinical trial NCT02809001: The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Scar
Nevus
Keywords: Fat grafting
Expansion-related complications
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 as skin thinning, telangiectasia, and striae may result in expansion failure and ultimately jeopardize final outcome. In the past years, discontinuation of the expansion procedure was the only therapeutic option, when early alarm signs such as semitransparent appearance and telangiectasia of the expanded skin were encountered. We aimed to overcome these complications by therapeutic fat grafting to prevent skin necrosis and enable continuation of the expansion procedure.

Patients undergoing soft tissue expansion treatment for resurfacing skin lesions including scars and nevi that required therapeutic intervention due to early complication signs were included in this study. Patients were randomly divided into treatment group using autologous fat grafting and control group with discontinued expansion and expectant management. The treatment group received autologous fat transfer to the expanded skin.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: To Measure the Change in Expansion Volume
timeFrame: Change from baseline volume at 12 weeks
measure: To Measure the Change in Skin Thickness
timeFrame: Change from baseline skin thickness at 12 weeks
Secondary outcomes:
measure: To Measure the Texture of Expanded Flap with VISIA scanner
timeFrame: baseline and 12 weeks post treatment
measure: Occurence of Major Adverse Events
timeFrame: Up to approximately 12 weeks after study start
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
Study officials:
References: