Autologous Fat Grafting to the Breast

Breast Reconstruction Clinical Trial

Official title:

Autologous Fat Grafting to the Breast

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00775788
• Other study ID #: 7006
• Status: Recruiting
• Phase: N/A
• First received: October 15, 2008
• Last updated: November 17, 2008
• Start date: June 2008
• Est. completion date: June 2010

Study information

• Verified date: October 2008
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: Kamran Khoobehi, MD
• Phone: 504-779-5538
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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%.

Description:

Our goal with this study is to prospectively acquire information with our protocol that will outline the accurate long-term outcomes of fat transfer to the breast. Currently, fat grafting to the breast is a treatment option in conditions such as micromastia, breast ptosis, post mastectomy breast reconstruction, asymmetric breasts, congenital malformations of breast development and for treatment of complications associated with implant augmentation mammoplasty. In addition to fat grafting, the current surgical treatment for these conditions is mainly based on techniques requiring implant augmentation or reconstruction. Although the safety of saline implants has been well studied and documented, this data cannot be extrapolated for the newer generation silicone implants and other alternatives such as fat grafting need to be investigated. Also implant augmentation and reconstruction comes at the price of capsular contracture, implant deflation, infection and more future corrective surgeries. We plan to prospectively study the outcomes of fat grafting in patients with these conditions for a period of 5 years. The collected information will be entered into a database and will be prospectively collected and reviewed. Patients demographics, information obtained during the preoperative and postoperative visits along with the pertinent findings regarding the fat transfer to the breast will be collected into the database for our investigation.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Ptosis
• Breast Reconstruction
• Congenital Abnormalities
• Congenital Malformations
• Implant Failure
• Micromastia

Intervention

Procedure:
• Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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