Brief 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%.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach

1 country

2 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

June 1, 2008

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed

Last Updated

November 18, 2008

Status Verified

October 1, 2008

Enrollment Period

2 years

First QC Date

October 15, 2008

Last Update Submit

November 17, 2008

Conditions

Micromastia Breast Ptosis Implant Failure Breast Reconstruction Congenital Malformations

Keywords

Fat Injection to BreastFat Grafting to Breast

Outcome Measures

Primary Outcomes (1)

3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons.
3 months, 6 months and annually

Secondary Outcomes (1)

Patient satisfaction with cosmetic and reconstructive results
3 months, 6 months and annually