Breast Reconstruction Clinical Trial
Official title:
Autologous Fat Grafting to the Breast
Structural fat grafting is a form of tissue transfer where the autologous fat is harvested and subsequently transferred to a different region of the body at the same setting. It is an excellent technique for filling soft tissue and contour defects. Fat has the benefit of being abundantly available and easy to harvest. Further more, it is cheap and autogenous and thus lacks the side effects of synthetic fillers or implants. Autogenous fat transfer is a relatively common procedure performed by plastic and reconstructive surgeons. The goal of fat grafting is to provide the patient with a predictable, long lasting autogenous soft tissue augmentation. Autogenous fat transfer has been used extensively as an adjunct to facial rejuvenation. As well it has been applied to body contouring and augmentation of the hips, trochanteric areas, thighs and buttocks, back, torso and breast. The transfer of autologous fat dates back to 1890s and more specifically as injectable grafts since the 1920s. However, over the past 20 years the popularity of structural fat grafting has increased as a contouring modality. Fat transfer to the breast, popularized by Coleman, has been performed internationally since the 1990s. Despite the duration, the literature lacks accurate outcomes data on fat transfer to the breast and questions regarding the viability of adipocytes after the transfer exist. Sources from various publications show cell viability of up to 100% however studies of long term clinical outcomes quote rates of 10% to 80%.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 17 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Women with the following conditions micromastia, breast ptosis, post mastectomy breast reconstruction, asymmetric breasts, congenital malformations of breast development and for treatment of complications associated with implant augmentation mammoplasty. Exclusion Criteria: - A volunteer who has a positive pregnancy test - A volunteer who has had a cardiac stent placed within the last two months - A volunteer with a known, current substance abuse - A volunteer with a bleeding diathesis - Untreated breast cancer - A volunteer who smokes cigarettes - Medical Conditions including untreated hypertension, renal disease, diabetes mellitus |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Houma Outpatient Surgery Center | Metairie | Louisiana |
United States | Medical Center of Louisiana New Orleans, LSU Health Sciences Center | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Louisiana State University Health Sciences Center in New Orleans |
United States,
Coleman SR, Saboeiro AP. Fat grafting to the breast revisited: safety and efficacy. Plast Reconstr Surg. 2007 Mar;119(3):775-85; discussion 786-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons. | 3 months, 6 months and annually | Yes | |
Secondary | Patient satisfaction with cosmetic and reconstructive results | 3 months, 6 months and annually | Yes |
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