Autologous Fat Grafting to the Breast

November 17, 2008 updated by: Louisiana State University Health Sciences Center in New Orleans
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%.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kamran Khoobehi, MD
  • Phone Number: 504-779-5538

Study Contact Backup

  • Name: Alireza Sadeghi, MD
  • Phone Number: 504-273-9800

Study Locations

  • United States
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Houma Outpatient Surgery Center
        • Contact:
        • Principal Investigator:
          • Kamran Khoobehi, MD
        • Sub-Investigator:
          • Alireza Sadeghi, MD
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Medical Center of Louisiana New Orleans, LSU Health Sciences Center
        • Principal Investigator:
          • Kamran Khoobehi, MD
        • Sub-Investigator:
          • Alireza Sadeghi, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 68 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implant Failure
Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Mastectomy
  • Breast Reconstruction
  • Implant related complications
Experimental: Post mastectomy breast reconstruction
Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Mastectomy
  • Breast Reconstruction
  • Implant related complications
Experimental: Congenital malformations
Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Mastectomy
  • Breast Reconstruction
  • Implant related complications
Experimental: Breast Ptosis
Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Mastectomy
  • Breast Reconstruction
  • Implant related complications
Experimental: Micromastia
Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Mastectomy
  • Breast Reconstruction
  • Implant related complications
Experimental: Asymmetric Breasts
Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Mastectomy
  • Breast Reconstruction
  • Implant related complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons.
Time Frame: 3 months, 6 months and annually
3 months, 6 months and annually

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction with cosmetic and reconstructive results
Time Frame: 3 months, 6 months and annually
3 months, 6 months and annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Investigators

  • Principal Investigator: Kamran Khoobehi, MD, LSUHSC
  • Study Director: Alireza Sadeghi, MD, LSUHSC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

October 15, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Estimate)

November 18, 2008

Last Update Submitted That Met QC Criteria

November 17, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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