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Autologous Fat Grafting to the Breast

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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

Tracking Information
First Submitted Date  ICMJE October 15, 2008
First Posted Date  ICMJE October 20, 2008
Last Update Posted Date November 18, 2008
Study Start Date  ICMJE June 2008
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons. [ Time Frame: 3 months, 6 months and annually ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00775788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
Patient satisfaction with cosmetic and reconstructive results [ Time Frame: 3 months, 6 months and annually ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Fat Grafting to the Breast
Official Title  ICMJE Autologous Fat Grafting to the Breast
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%.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Micromastia
  • Breast Ptosis
  • Implant Failure
  • Breast Reconstruction
  • Congenital Malformations
Intervention  ICMJE Procedure: Autologous Fat Grafting to Breasts
Fat injection of Fat to breasts
Other Names:
  • Breast Reconstruction
  • Implant related complications
  • Mastectomy
Study Arms  ICMJE
  • Experimental: Implant Failure
    Intervention: Procedure: Autologous Fat Grafting to Breasts
  • Experimental: Post mastectomy breast reconstruction
    Intervention: Procedure: Autologous Fat Grafting to Breasts
  • Experimental: Congenital malformations
    Intervention: Procedure: Autologous Fat Grafting to Breasts
  • Experimental: Breast Ptosis
    Intervention: Procedure: Autologous Fat Grafting to Breasts
  • Experimental: Micromastia
    Intervention: Procedure: Autologous Fat Grafting to Breasts
  • Experimental: Asymmetric Breasts
    Intervention: Procedure: Autologous Fat Grafting to Breasts
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 17, 2008)
50
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2008)
100
Estimated Study Completion Date  ICMJE June 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 17 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00775788
Other Study ID Numbers  ICMJE 7006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kamran Khoobehi MD FACS, LSUHSC
Study Sponsor  ICMJE Louisiana State University Health Sciences Center in New Orleans
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kamran Khoobehi, MD LSUHSC
Study Director: Alireza Sadeghi, MD LSUHSC
PRS Account Louisiana State University Health Sciences Center in New Orleans
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP