Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Georgetown University |
---|---|
Information provided by: | Georgetown University |
ClinicalTrials.gov Identifier: | NCT00663156 |
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 |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Single Group Assignment |
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
|
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).
Ages Eligible for Study: | 20 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Scott L Spear, MD | 202-444-8612 | spears@gunet.georgetown.edu |
Contact: Mary Beth Brubeck, RN | 202-444-1805 | meb109@gunet.georgetown.edu |
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 |
Principal Investigator: | Scott L Spear, MD | Georgetown University hospital |
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 |
lipoaugmentation breast augmentation fat grafting liposuction lipoinfiltration Spear breast implants |
ASERF Lipivage Baker harvest autologous Georgetown |