MedDataX Logo

Autologous Fat Grafting to the Breast

NCT ID: NCT00775788

Last Updated: 2008-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Micromastia Breast Ptosis Implant Failure Breast Reconstruction Congenital Malformations

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Fat Injection to Breast Fat Grafting to Breast

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Implant Failure

Group Type EXPERIMENTAL

Autologous Fat Grafting to Breasts

Intervention Type PROCEDURE

Fat injection of Fat to breasts

Post mastectomy breast reconstruction

Group Type EXPERIMENTAL

Autologous Fat Grafting to Breasts

Intervention Type PROCEDURE

Fat injection of Fat to breasts

Congenital malformations

Group Type EXPERIMENTAL

Autologous Fat Grafting to Breasts

Intervention Type PROCEDURE

Fat injection of Fat to breasts

Breast Ptosis

Group Type EXPERIMENTAL

Autologous Fat Grafting to Breasts

Intervention Type PROCEDURE

Fat injection of Fat to breasts

Micromastia

Group Type EXPERIMENTAL

Autologous Fat Grafting to Breasts

Intervention Type PROCEDURE

Fat injection of Fat to breasts

Asymmetric Breasts

Group Type EXPERIMENTAL

Autologous Fat Grafting to Breasts

Intervention Type PROCEDURE

Fat injection of Fat to breasts

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autologous Fat Grafting to Breasts

Fat injection of Fat to breasts

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Breast Reconstruction Implant related complications Mastectomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

LSUHSC

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kamran Khoobehi, MD

Role: PRINCIPAL_INVESTIGATOR

LSUHSC

Alireza Sadeghi, MD

Role: STUDY_DIRECTOR

LSUHSC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Houma Outpatient Surgery Center

Metairie, Louisiana, United States

Site Status RECRUITING

Medical Center of Louisiana New Orleans, LSU Health Sciences Center

New Orleans, Louisiana, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kamran Khoobehi, MD

Role: CONTACT

Phone: 504-779-5538

Alireza Sadeghi, MD

Role: CONTACT

Phone: 504-273-9800

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kamran Khoobehi, MD

Role: primary

Kamran Khoobehi, MD FACS

Role: primary

Alireza Sadeghi, MD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 17312477 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.khoobehi.com

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7006

Identifier Type: -

Identifier Source: org_study_id