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Autologous Fat Grafting to the Breast

Primary Purpose

Micromastia, Breast Ptosis, Implant Failure

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autologous Fat Grafting to Breasts
Sponsored by
Louisiana State University Health Sciences Center in New Orleans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Micromastia focused on measuring Fat Injection to Breast, Fat Grafting to Breast

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Houma Outpatient Surgery CenterRecruiting
  • Medical Center of Louisiana New Orleans, LSU Health Sciences CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Implant Failure

Post mastectomy breast reconstruction

Congenital malformations

Breast Ptosis

Micromastia

Asymmetric Breasts

Arm Description

Outcomes

Primary Outcome Measures

3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons.

Secondary Outcome Measures

Patient satisfaction with cosmetic and reconstructive results

Full Information

First Posted
October 15, 2008
Last Updated
November 17, 2008
Sponsor
Louisiana State University Health Sciences Center in New Orleans
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1. Study Identification

Unique Protocol Identification Number
NCT00775788
Brief Title
Autologous Fat Grafting to the Breast
Official Title
Autologous Fat Grafting to the Breast
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Micromastia, Breast Ptosis, Implant Failure, Breast Reconstruction, Congenital Malformations
Keywords
Fat Injection to Breast, Fat Grafting to Breast

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implant Failure
Arm Type
Experimental
Arm Title
Post mastectomy breast reconstruction
Arm Type
Experimental
Arm Title
Congenital malformations
Arm Type
Experimental
Arm Title
Breast Ptosis
Arm Type
Experimental
Arm Title
Micromastia
Arm Type
Experimental
Arm Title
Asymmetric Breasts
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Autologous Fat Grafting to Breasts
Other Intervention Name(s)
Breast Reconstruction, Implant related complications, Mastectomy
Intervention Description
Fat injection of Fat to breasts
Primary Outcome Measure Information:
Title
3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons.
Time Frame
3 months, 6 months and annually
Secondary Outcome Measure Information:
Title
Patient satisfaction with cosmetic and reconstructive results
Time Frame
3 months, 6 months and annually

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamran Khoobehi, MD
Phone
504-779-5538
First Name & Middle Initial & Last Name or Official Title & Degree
Alireza Sadeghi, MD
Phone
504-273-9800
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamran Khoobehi, MD
Organizational Affiliation
LSUHSC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alireza Sadeghi, MD
Organizational Affiliation
LSUHSC
Official's Role
Study Director
Facility Information:
Facility Name
Houma Outpatient Surgery Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamran Khoobehi, MD
Phone
504-779-5538
Email
khoobehi@aol.com
First Name & Middle Initial & Last Name & Degree
Kamran Khoobehi, MD
First Name & Middle Initial & Last Name & Degree
Alireza Sadeghi, MD
Facility Name
Medical Center of Louisiana New Orleans, LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamran Khoobehi, MD FACS
Phone
504-779-5538
Email
khoobehi@aol.com
First Name & Middle Initial & Last Name & Degree
Alireza Sadeghi, MD
Email
dssadeghi@yahoo.com
First Name & Middle Initial & Last Name & Degree
Kamran Khoobehi, MD
First Name & Middle Initial & Last Name & Degree
Alireza Sadeghi, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17312477
Citation
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. doi: 10.1097/01.prs.0000252001.59162.c9.
Results Reference
result
Links:
URL
http://www.khoobehi.com
Description
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Autologous Fat Grafting to the Breast

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