MicromastiaNCT00775788
Autologous Fat Grafting to the Breast
A study testing Autologous Fat Grafting to Breasts in people with Micromastia and Breast Ptosis, run by Louisiana State University Health Sciences Center in New Orleans at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Micromastia, Breast Ptosis, Implant Failure
- What is being tested?
- Autologous Fat Grafting to Breasts
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 70 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Kamran Khoobehi, MD contact
Alireza Sadeghi, MD contact
United States2 sites, 2 recruiting
- Recruiting
Houma Outpatient Surgery Center
Metairie, Louisiana, 70006
Kamran Khoobehi, MD, 504-779-5538, khoobehi@aol.com
Kamran Khoobehi, MD
- Recruiting
Medical Center of Louisiana New Orleans, LSU Health Sciences Center
New Orleans, Louisiana, 70112
Kamran Khoobehi, MD FACS, 504-779-5538, khoobehi@aol.com
Alireza Sadeghi, MD, dssadeghi@yahoo.com
About this study
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%.
Read the 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.
- Conditions
- Micromastia, Breast Ptosis, Implant Failure, Breast Reconstruction, Congenital Malformations
- Being tested
- Autologous Fat Grafting to Breasts
- Keywords
- Fat Injection to Breast, Fat Grafting to Breast
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fat Grafting to BreastsProcedure or surgery
Also called Breast Reconstruction, Implant related complications, Mastectomy
Fat injection of Fat to breasts
| Study group | Role | What they receive |
|---|---|---|
| Implant Failure | Experimental | Not described Receives: Procedure: Autologous Fat Grafting to Breasts |
| Post mastectomy breast reconstruction | Experimental | Not described Receives: Procedure: Autologous Fat Grafting to Breasts |
| Congenital malformations | Experimental | Not described Receives: Procedure: Autologous Fat Grafting to Breasts |
| Breast Ptosis | Experimental | Not described Receives: Procedure: Autologous Fat Grafting to Breasts |
| Micromastia | Experimental | Not described Receives: Procedure: Autologous Fat Grafting to Breasts |
| Asymmetric Breasts | Experimental | Not described Receives: Procedure: Autologous Fat Grafting to Breasts |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons.
Measured: 3 months, 6 months and annually
Secondary outcomes (1)
Patient satisfaction with cosmetic and reconstructive results
Measured: 3 months, 6 months and annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicromastiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Investigators
- Kamran Khoobehi, MD, Principal investigator, LSUHSCAlireza Sadeghi, MD, Study director, LSUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775788
- Sponsor's protocol ID
- 7006
- Status last verified
- Oct 2008
- First submitted
- 15 Oct 2008
- Last updated
- 18 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17312477
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Fat Grafting to the Breast
- ClinicalTrials.gov ID
- NCT00775788
- Acronym / sponsor ID
- 7006
- Conditions
- Micromastia, Breast Ptosis, Implant Failure, Breast Reconstruction, Congenital Malformations
- Keywords
- Fat Injection to Breast, Fat Grafting to Breast
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Implant Failure | Experimental | Procedure: Autologous Fat Grafting to Breasts |
| Post mastectomy breast reconstruction | Experimental | Procedure: Autologous Fat Grafting to Breasts |
| Congenital malformations | Experimental | Procedure: Autologous Fat Grafting to Breasts |
| Breast Ptosis | Experimental | Procedure: Autologous Fat Grafting to Breasts |
| Micromastia | Experimental | Procedure: Autologous Fat Grafting to Breasts |
| Asymmetric Breasts | Experimental | Procedure: Autologous Fat Grafting to Breasts |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Fat Grafting to BreastsAlso: Breast Reconstruction, Implant related complications, MastectomyFat injection of Fat to breasts | Procedure or surgery | Asymmetric Breasts, Breast Ptosis, Congenital malformations, Implant Failure, Micromastia, Post mastectomy breast reconstruction |
Primary outcome
3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons.
Time frame: 3 months, 6 months and annually
1 secondary outcome
Patient satisfaction with cosmetic and reconstructive results
Time frame: 3 months, 6 months and annually
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2008.
- Results publication: PubMed 17312477Coleman 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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamran Khoobehi, MD contact
Alireza Sadeghi, MD contact
Kamran Khoobehi, MD principal investigator
LSUHSC
Alireza Sadeghi, MD study director
LSUHSC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Fat Grafting to Breasts in people with Micromastia and Breast Ptosis, run by Louisiana State University Health Sciences Center in New Orleans at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamran Khoobehi, MD (504-779-5538), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 Dimensional volumetric analysis of results and photographic analysis by board certified plastic surgeons. (time frame: 3 months, 6 months and annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00775788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2008.