The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure

Scar Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809001
• Other study ID #: Shanghai9PH
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 5, 2016
• Last updated: June 17, 2016
• Start date: January 2011
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nevus
• Scar

Intervention

Procedure:
• Fat grafting
In the experimental group, 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.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Measure the Change in Expansion Volume	Record the volume(ml) of each expander	Change from baseline volume at 12 weeks	No
Primary	To Measure the Change in Skin Thickness	Record the thickness of the expanded skin(cm) by ultrasound scanning	Change from baseline skin thickness at 12 weeks	No
Secondary	To Measure the Texture of Expanded Flap with VISIA scanner	Evaluate skin texture with VISIA scanner and compare the characteristics	baseline and 12 weeks post treatment	No
Secondary	Occurence of Major Adverse Events	Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events	Up to approximately 12 weeks after study start	Yes