Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous Fat Grafting to the Breast

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00775788
Recruitment Status : Unknown
Verified October 2008 by Louisiana State University Health Sciences Center in New Orleans.
Recruitment status was:  Recruiting
First Posted : October 20, 2008
Last Update Posted : November 18, 2008
Sponsor:
Information provided by:
Louisiana State University Health Sciences Center in New Orleans

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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%.

Condition or disease Intervention/treatment Phase
Micromastia Breast Ptosis Implant Failure Breast Reconstruction Congenital Malformations Procedure: Autologous Fat Grafting to Breasts Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Fat Grafting to the Breast
Study Start Date : June 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons. [ Time Frame: 3 months, 6 months and annually ]

Secondary Outcome Measures :
  1. Patient satisfaction with cosmetic and reconstructive results [ Time Frame: 3 months, 6 months and annually ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775788


Contacts
Layout table for location contacts
Contact: Kamran Khoobehi, MD 504-779-5538
Contact: Alireza Sadeghi, MD 504-273-9800

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Kamran Khoobehi, MD LSUHSC
Study Director: Alireza Sadeghi, MD LSUHSC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Layout table for additonal information
Responsible Party: Kamran Khoobehi MD FACS, LSUHSC
ClinicalTrials.gov Identifier: NCT00775788    
Other Study ID Numbers: 7006
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: November 18, 2008
Last Verified: October 2008
Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
Fat Injection to Breast
Fat Grafting to Breast
Additional relevant MeSH terms:
Layout table for MeSH terms
Congenital Abnormalities