Autologous Fat Grafting to the Breast

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Louisiana State University Health Sciences Center in New Orleans.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT00775788
First received: October 15, 2008
Last updated: November 17, 2008
Last verified: October 2008
  Purpose

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%.


Condition Intervention
Micromastia
Breast Ptosis
Implant Failure
Breast Reconstruction
Congenital Malformations
Procedure: Autologous Fat Grafting to Breasts

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Fat Grafting to the Breast

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:

Primary Outcome Measures:
  • 3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons. [ Time Frame: 3 months, 6 months and annually ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient satisfaction with cosmetic and reconstructive results [ Time Frame: 3 months, 6 months and annually ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: June 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implant Failure Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Breast Reconstruction
  • Implant related complications
  • Mastectomy
Experimental: Post mastectomy breast reconstruction Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Breast Reconstruction
  • Implant related complications
  • Mastectomy
Experimental: Congenital malformations Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Breast Reconstruction
  • Implant related complications
  • Mastectomy
Experimental: Breast Ptosis Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Breast Reconstruction
  • Implant related complications
  • Mastectomy
Experimental: Micromastia Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Breast Reconstruction
  • Implant related complications
  • Mastectomy
Experimental: Asymmetric Breasts Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Breast Reconstruction
  • Implant related complications
  • Mastectomy

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.

  Eligibility

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775788

Contacts
Contact: Kamran Khoobehi, MD 504-779-5538
Contact: Alireza Sadeghi, MD 504-273-9800

Locations
United States, Louisiana
Houma Outpatient Surgery Center Recruiting
Metairie, Louisiana, United States, 70006
Contact: Kamran Khoobehi, MD    504-779-5538    khoobehi@aol.com   
Principal Investigator: Kamran Khoobehi, MD         
Sub-Investigator: Alireza Sadeghi, MD         
Medical Center of Louisiana New Orleans, LSU Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Kamran Khoobehi, MD FACS    504-779-5538    khoobehi@aol.com   
Contact: Alireza Sadeghi, MD       dssadeghi@yahoo.com   
Principal Investigator: Kamran Khoobehi, MD         
Sub-Investigator: Alireza Sadeghi, MD         
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Investigators
Principal Investigator: Kamran Khoobehi, MD LSUHSC
Study Director: Alireza Sadeghi, MD LSUHSC
  More Information

Additional Information:
Publications:
Responsible Party: Kamran Khoobehi MD FACS, LSUHSC
ClinicalTrials.gov Identifier: NCT00775788     History of Changes
Other Study ID Numbers: 7006
Study First Received: October 15, 2008
Last Updated: November 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
Fat Injection to Breast
Fat Grafting to Breast

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 17, 2014