A Prospective Study of Autologous Fat Grafting for Breast Augmentation

Breast Augmentation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663156
• Other study ID #: 4359-617
• Status: Completed
• Phase: N/A
• First received: April 1, 2008
• Last updated: February 14, 2013
• Start date: March 2008
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

• must reside within 50 miles of the Washington, D.C. Metropolitan area

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Augmentation
• Fat Grafting

Intervention

Procedure:
• breast implants
patients will have breast augmentation using implants
• 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.

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		One year post-op	No
Secondary	Patients will be evaluated by mammogram, MRI, and 3-D photography to monitor for breast tissue abnormalities and measure increase in volume		one year	No

External Links

•   plastic surgery Dr. Scott Spear