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A Prospective Study of Autologous Fat Grafting for Breast Augmentation
This study is currently recruiting participants.
Verified by Georgetown University, April 2008
Sponsored by: Georgetown University
Information provided by: Georgetown University
ClinicalTrials.gov Identifier: NCT00663156
  Purpose

This research study is to evaluate the natural history of fat transplanted from a person's body to their breasts. We are seeking a natural, safe, and effective alternative to breast implants. Patients will undergo liposuction of their body followed by infiltration of this harvested fat around their breasts. The study protocol will involve preoperative and postoperative photographs, mammograms, and MRI to look for changes in the breast shape and size, as well as any internal changes in the breast tissue.


Condition Intervention
Breast Augmentation
Fat Grafting
Procedure: breast implants
Procedure: Liposuction, fat grafting

MedlinePlus related topics: Breast Reconstruction
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Open Label, Single Group Assignment

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Effectiveness will be evaluated by comparing breast volume pre-operatively and at 1 year post-operatively using 3-dimensional picture imaging to obtain objective volume measurements. [ Time Frame: One year post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients will be evaluated by mammogram, MRI, and 3-D photography to monitor for breast tissue abnormalities and measure increase in volume [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
subject: Experimental
10 subjects receiving breast augmentation with fat grafting
Procedure: Liposuction, fat grafting
Autologous fat will be harvested from the body (typically the abdomen or thighs) using syringe aspiration techniques and then infiltrated into the subcutaneous tissue around the breast as well as between the breast and the underlying musculature using blunt cannulas. These procedures will be done in an outpatient surgery setting in the Georgetown University Hospital under general anesthesia and sterile conditions.
control
10 control will have breast augmentation using breast implants
Procedure: breast implants
patients will have breast augmentation using implants

Detailed Description:

The current standard for breast augmentation involves placement of an implant. Although implants are safe, they are foreign bodies and thus have inherent risks including infection, failure, malposition, etc. In order to avoid the inherent risks of an implanted device, some surgeons and patients have elected to proceed with breast augmentation from autologous tissue. Early reports of autologous fat transplantation to the breasts were successful, but increases in breast volume were modest (Bircoll, 1987). There were also hypothetical concerns about changes in the breast tissue that would interfere with mammographic screening for breast cancer.

Spear et al (2005) performed autologous fat transplantation to reconstructed breasts in 37 patients with 2-dimensional photographic evidence of improved breast shape and volume suggesting that this technique can be effectively performed. However, these patients had all received mastectomies so mammographic screening was not indicated. Coleman and Saboeiro (2007) performed autologous fat transplantation to the breasts in 17 patients. Fifteen of the 17 patients received post-operative mammograms, 7 (47%) of which were abnormal. However, none of these abnormal findings interfered with cancer screening. Furthermore, 2 patients in the study did develop breast cancer which was successfully detected by mammography. Other studies have confirmed the ability to differentiate benign from malignant findings on mammogram after autologous fat transplantation. Pulagam et al (2006) reported long term (10 and 8 year) findings on 2 patients that underwent autologous fat transplantation to the breasts. Mammography and ultrasound were used to differentiate benign from malignant appearing calcifications. Some authors have speculated that autologous fat transplantation to the breast would lead to mammographic changes similar to routine breast procedures such as breast reduction and mastopexy (Coleman and Saboeiro, 2007).

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20-50 years old
  • willing to have mammogram, MRI, and photographs
  • willing to follow study requirements and sign informed consent
  • no previous breast surgeries

Exclusion Criteria:

  • pregnant or nursing
  • existing breast cancer
  • advanced fibrocystic disease
  • protease inhibitors
  • any condition leading to surgical risk
  • any disease known to affect wound healing
  • abscess or infection in the body
  • incompatible psychological factors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663156

Contacts
Contact: Scott L Spear, MD 202-444-8612 spears@gunet.georgetown.edu
Contact: Mary Beth Brubeck, RN 202-444-1805 meb109@gunet.georgetown.edu

Locations
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Scott L Spear, MD     202-444-8612     spears@gunet.georgetown.edu    
Contact: Mary Beth Brubeck, RN     202-444-1805     meb109@gunet.georgetown.edu    
Principal Investigator: Scott L Spear, MD            
Sub-Investigator: Stephen Baker, MD            
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Scott L Spear, MD Georgetown University hospital
  More Information

plastic surgery Dr. Scott Spear  This link exits the ClinicalTrials.gov site

Responsible Party: Georgetown University Hospital ( Scott L. Spear, M.D., Professor and Chief, Dept. Plastic Surgery )
Study ID Numbers: 4359-617
Study First Received: April 1, 2008
Last Updated: April 21, 2008
ClinicalTrials.gov Identifier: NCT00663156  
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
lipoaugmentation
breast augmentation
fat grafting
liposuction
lipoinfiltration
Spear
breast implants
ASERF
Lipivage
Baker
harvest
autologous
Georgetown

ClinicalTrials.gov processed this record on January 16, 2009