Breast AsymmetryNCT05318716
The Fat Analysis Trial (FAT) - Assessing the Impact of Lipo-aspirate Processing
A study testing Fat grafting - Revolve device and Fat grafting - Decantation in people with Breast Asymmetry and Fat Atrophy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Fat grafting has been gaining popularity over the past decade. It is now commonly used for breast augmentation and reconstruction, however a major challenge remains the high rate and unpredictable rate of fat resorption post-operatively, leading to volume loss and patient dissatisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Asymmetry, Fat Atrophy
- What is being tested?
- Fat grafting - Revolve device and Fat grafting - Decantation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Jul 2025
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient above the age of 18 undergoing fat grafting from any donor site to the breast for cosmetic or reconstructive purposes.
- We will accept patient who have an implant for either cosmetic or reconstructive purposes
Who cannot join
- Previous fat grafting
- Autologous breast reconstruction (regional or free flap)
- unable to consent to the study
Trial locations and contacts
No sites are listed yet.
Khalifa AlGhanim, MD contact
About this study
Official title: The Fat Analysis Trial (FAT): The Impact of Lip-aspirate Processing on Fat Resorption in Autologous Fat Grafting to the Breast: A Randomized Controlled Trial
Fat grafting has been gaining popularity over the past decade. It is now commonly used for breast augmentation and reconstruction, however a major challenge remains the high rate and unpredictable rate of fat resorption post-operatively, leading to volume loss and patient dissatisfaction. Currently there is no consensus on the ideal technique to process donor fat to minimize the rate of resorption. Our study aims to compare two common processing methods to determine if one is superior for fat volume retention.
Read the detailed description
Fat grafting is a technique used commonly in plastic surgery that has gained popularity in breast augmentation and breast reconstruction. This technique involves harvesting fat using liposuction from donor sites, processing the extracted fat and re-injecting it back into the breast for the desired volume and shape. Fat grafting has gained popularity due to its resulting natural appearance and feel. This technique can also be used in conjunction with implant reconstruction to achieve a more natural contour and symmetry. However, the main issue is a low rate of fat retention, which, based on the literature, is inconsistent and only an average of 60% of the volume of fat injected. Furthermore, there are very few clinical studies studying the long-term clinical survivability of the grafted fat. Therefore, care must be taken in setting patient expectations, and sometimes multiple sessions are required to achieve the desired results.
There are currently multiple techniques used in harvesting and processing fat for grafting, and it is unclear in the current literature if the processing technique used affects the level of fat resorption. General principles of fat grafting include gentle extraction to avoid damage and processing to remove excess infiltration fluid and impurities before injection. The fat is collected from donor areas for extraction, using either manual or power-assisted liposuction. For processing, several products and processing solutions have been developed in recent years, including the Revolve system (AbbVie/Allergan), which is currently used at our institution. Prior to these systems, simple decantation of fat by gravity or centrifugation was used. However, due to damage to fat during processing and lower retention rates in the literature, centrifugation has largely been abandoned as a processing method. However, there is no standard method of donor fat harvest or processing, and there is a lack of well-defined prospective clinical studies comparing popular techniques in the current literature, particularly in the long term. Additionally, the amount of fat injected and patient factors such as previous radiation can affect the amount of fat retention. Further in-vitro studies are required to clarify factors that affect fat survivability.
In order to assess the rate of fat retention in the breast, quantitative imaging tools have been validated in the literature. One of the most popular techniques is 3D body surface scans. These can be taken easily, quickly, and cost-effectively for volume assessment at various time points pre and postoperatively. Comparatively, MRI imaging is costly, time-consuming and therefore not practical for frequent follow-up. Furthermore, as 3D imaging becomes more accessible, its use could become more common in clinical practice for preoperative planning and objective assessment of outcomes.
Methods Aims Currently, there is a lack of prospective clinical studies directly comparing the rate of fat graft retention between processing techniques. Our primary outcome aims to compare two common processing methods; decantation and the Revolve system. Investigators will measure the retention rate using 3D imaging techniques (Vectra H2, Canfield), in the place of traditional 2D photography, for quantitative measurement of breast volume. Our secondary outcomes include the assessment of operating time, cost, and collect secondary outcomes related to surgical complications and outcomes. Investigators will tangentially perform a qualitative review of the patient's pre and post-operatively using the validated Breast-Q questionnaire. This study will be conducted at LHSC sites in London, Ontario.
- Conditions
- Breast Asymmetry, Fat Atrophy
- Being tested
- Fat grafting - Revolve device, Fat grafting - Decantation
- Keywords
- Fat grafting, Fat survival, Breast surgery
- Medical subject headings
- Anisomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat grafting - Revolve deviceDevice
Standardized fat collection The donor areas previously agreed on by the patient and surgeon for fat harvesting will be injected with pre-standardized formulae and volume of tumescent fluid, and fat will be extracted using a standardized harvesting method between surgeons. Once the fat is collected. It will then be processed in one of two ways depending on the patient's group, using a Revolve system or via decantation. Fat will then be injected into the breast using a 10 or 20cc syringe in the standard retrograde manner to achieve the desired size and shape. A standard gauze-based dressing will be applied post-operatively, with no compression.
Fat grafting - DecantationDevice
Standardized fat collection The donor areas previously agreed on by the patient and surgeon for fat harvesting will be injected with pre-standardized formulae and volume of tumescent fluid, and fat will be extracted using a standardized harvesting method between surgeons. Once the fat is collected. It will then be processed in one of two ways depending on the patient's group, using a Revolve system or via decantation. Fat will then be injected into the breast using a 10 or 20cc syringe in the standard retrograde manner to achieve the desired size and shape. A standard gauze-based dressing will be applied post-operatively, with no compression.
| Study group | Role | What they receive |
|---|---|---|
| Reconstructive group | Experimental | This group of patients would be undergoing fat grafting following implant-based reconstruction. We will be excluding patients that have had autologous based reconstruction, including regional and free flaps. This group will be analyzed based on volume (<200cc or 50% and >200cc or 50%) as well as subgroup analysis based on adjuvant chemo or radiation therapy. Receives: Device: Fat grafting - Revolve device; Device: Fat grafting - Decantation |
| Cosmetic augmentation group | Experimental | This group of patients will be undergoing a primary or secondary augmentation for cosmesis. They will be included if this is a primary augmentation using fat grafting or a secondary augmentation with no history of fat grafting to the breasts. Receives: Device: Fat grafting - Revolve device; Device: Fat grafting - Decantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. What is the volume of fat retained between the two most common methods of fat processing?
Volume based Sub-division based on 3D volumetric analysis. Height (in metres) and weight (in kilograms) will be recorded to calculate BMI. This will be needed to assess weight stability during the follow up period.
Each of the above groups will be stratified based on breast volume, as well as injected volume. Each group will be divided into low volume, which will be less than 200cc of injected fat or 50% of breast volume, whichever is greater. The high-volume group will include volumes greater than 200cc or 50% of breast volume.
Imaging A Vectra H2 (Canfield medical, NJ) will capture a 3D image in place of our traditional 2D imaging, for both pre-operative and post-operative photos. A volumetric analysis will be performed using the proprietary software. With a pre-operative baseline volume, we will be able to track fat survival between the two-methods post-operatively during follow up visits.
Total follow up time will be 24 months post-operatively.
Measured: 12 months recruitment and 24 months follow up
How satisfied are the patients between each method of fat grafting?
We will tangentially perform a qualitative review of the patient's pre and post-operatively using the validated Breast-Q questionnaire. The BREAST-Q module for women who undergo breast augmentation is a rigorously developed PROM that is comprised of 9 independently functioning scales. It has undergone extensive psychometric evaluation and its developers report that it may be used like interval-scale data. Scores from these instruments are scaled to range from 0 to 100. This study will be conducted at affiliated clinical sites in London, Ontario.
Measured: 36 months total
Secondary outcomes (1)
3. Does one method of fat processing have a reduced rate of short, or long term complications?
the assessment of operating time (recorded in minutes) from the time tumescence is injected, until the injecting is complete. The additional cost of the device will be accounted for in the analysis (in US dollars), and collect secondary outcomes related to surgical complications and outcomes. These will be recorded prospectively and classified into minor and major, where major would be considered if needing surgery to correct an issue.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AsymmetryStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled trial, we aim to recruit patients already scheduled to undergo fat grafting to the breast for reconstruction or cosmetic augmentation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya DeLyzer, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318716
- Sponsor's protocol ID
- 11811
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: This is an ongoing discussion. At present there is a slight lean towards not making individual participant data available. This is to protect patient information during inclusion in this trial.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fat Analysis Trial (FAT): The Impact of Lip-aspirate Processing on Fat Resorption in Autologous Fat Grafting to the Breast: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05318716
- Acronym / sponsor ID
- 11811
- Conditions
- Breast Asymmetry, Fat Atrophy
- Keywords
- Fat grafting, Fat survival, Breast surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 8 Apr 2022 (actual)
- 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.
Fat grafting has been gaining popularity over the past decade. It is now commonly used for breast augmentation and reconstruction, however a major challenge remains the high rate and unpredictable rate of fat resorption post-operatively, leading to volume loss and patient dissatisfaction. Currently there is no consensus on the ideal technique to process donor fat to minimize the rate of resorption. Our study aims to compare two common processing methods to determine if one is superior for fat volume retention.
Detailed description
Fat grafting is a technique used commonly in plastic surgery that has gained popularity in breast augmentation and breast reconstruction. This technique involves harvesting fat using liposuction from donor sites, processing the extracted fat and re-injecting it back into the breast for the desired volume and shape. Fat grafting has gained popularity due to its resulting natural appearance and feel. This technique can also be used in conjunction with implant reconstruction to achieve a more natural contour and symmetry. However, the main issue is a low rate of fat retention, which, based on the literature, is inconsistent and only an average of 60% of the volume of fat injected. Furthermore, there are very few clinical studies studying the long-term clinical survivability of the grafted fat. Therefore, care must be taken in setting patient expectations, and sometimes multiple sessions are required to achieve the desired results.
There are currently multiple techniques used in harvesting and processing fat for grafting, and it is unclear in the current literature if the processing technique used affects the level of fat resorption. General principles of fat grafting include gentle extraction to avoid damage and processing to remove excess infiltration fluid and impurities before injection. The fat is collected from donor areas for extraction, using either manual or power-assisted liposuction. For processing, several products and processing solutions have been developed in recent years, including the Revolve system (AbbVie/Allergan), which is currently used at our institution. Prior to these systems, simple decantation of fat by gravity or centrifugation was used. However, due to damage to fat during processing and lower retention rates in the literature, centrifugation has largely been abandoned as a processing method. However, there is no standard method of donor fat harvest or processing, and there is a lack of well-defined prospective clinical studies comparing popular techniques in the current literature, particularly in the long term. Additionally, the amount of fat injected and patient factors such as previous radiation can affect the amount of fat retention. Further in-vitro studies are required to clarify factors that affect fat survivability.
In order to assess the rate of fat retention in the breast, quantitative imaging tools have been validated in the literature. One of the most popular techniques is 3D body surface scans. These can be taken easily, quickly, and cost-effectively for volume assessment at various time points pre and postoperatively. Comparatively, MRI imaging is costly, time-consuming and therefore not practical for frequent follow-up. Furthermore, as 3D imaging becomes more accessible, its use could become more common in clinical practice for preoperative planning and objective assessment of outcomes.
Methods Aims Currently, there is a lack of prospective clinical studies directly comparing the rate of fat graft retention between processing techniques. Our primary outcome aims to compare two common processing methods; decantation and the Revolve system. Investigators will measure the retention rate using 3D imaging techniques (Vectra H2, Canfield), in the place of traditional 2D photography, for quantitative measurement of breast volume. Our secondary outcomes include the assessment of operating time, cost, and collect secondary outcomes related to surgical complications and outcomes. Investigators will tangentially perform a qualitative review of the patient's pre and post-operatively using the validated Breast-Q questionnaire. This study will be conducted at LHSC sites in London, Ontario.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled trial, we aim to recruit patients already scheduled to undergo fat grafting to the breast for reconstruction or cosmetic augmentation.
| Arm | Type | Receives |
|---|---|---|
| Reconstructive group | Experimental | Device: Fat grafting - Revolve device, Device: Fat grafting - DecantationThis group of patients would be undergoing fat grafting following implant-based reconstruction. We will be excluding patients that have had autologous based reconstruction, including regional and free flaps. This group will be analyzed based on volume (<200cc or 50% and >200cc or 50%) as well as subgroup analysis based on adjuvant chemo or radiation therapy. |
| Cosmetic augmentation group | Experimental | Device: Fat grafting - Revolve device, Device: Fat grafting - DecantationThis group of patients will be undergoing a primary or secondary augmentation for cosmesis. They will be included if this is a primary augmentation using fat grafting or a secondary augmentation with no history of fat grafting to the breasts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient above the age of 18 undergoing fat grafting from any donor site to the breast for cosmetic or reconstructive purposes.
- We will accept patient who have an implant for either cosmetic or reconstructive purposes
Key exclusion criteria (3 listed)
- Previous fat grafting
- Autologous breast reconstruction (regional or free flap)
- unable to consent to the study
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 |
|---|---|---|
| Fat grafting - Revolve deviceStandardized fat collection The donor areas previously agreed on by the patient and surgeon for fat harvesting will be injected with pre-standardized formulae and volume of tumescent fluid, and fat will be extracted using a standardized harvesting method between surgeons. Once the fat is collected. It will then be processed in one of two ways depending on the patient's group, using a Revolve system or via decantation. Fat will then be injected into the breast using a 10 or 20cc syringe in the standard retrograde manner to achieve the desired size and shape. A standard gauze-based dressing will be applied post-operatively, with no compression. | Device | Cosmetic augmentation group, Reconstructive group |
| Fat grafting - DecantationStandardized fat collection The donor areas previously agreed on by the patient and surgeon for fat harvesting will be injected with pre-standardized formulae and volume of tumescent fluid, and fat will be extracted using a standardized harvesting method between surgeons. Once the fat is collected. It will then be processed in one of two ways depending on the patient's group, using a Revolve system or via decantation. Fat will then be injected into the breast using a 10 or 20cc syringe in the standard retrograde manner to achieve the desired size and shape. A standard gauze-based dressing will be applied post-operatively, with no compression. | Device | Cosmetic augmentation group, Reconstructive group |
Primary outcome
1. What is the volume of fat retained between the two most common methods of fat processing?
Time frame: 12 months recruitment and 24 months follow up
Volume based Sub-division based on 3D volumetric analysis. Height (in metres) and weight (in kilograms) will be recorded to calculate BMI. This will be needed to assess weight stability during the follow up period. Each of the above groups will be stratified based on breast volume, as well as injected volume. Each group will be divided into low volume, which will be less than 200cc of injected fat or 50% of breast volume, whichever is greater. The high-volume group will include volumes greater than 200cc or 50% of breast volume. Imaging A Vectra H2 (Canfield medical, NJ) will capture a 3D image in place of our traditional 2D imaging, for both pre-operative and post-operative photos. A volumetric analysis will be performed using the proprietary software. With a pre-operative baseline volume, we will be able to track fat survival between the two-methods post-operatively during follow up visits. Total follow up time will be 24 months post-operatively.
How satisfied are the patients between each method of fat grafting?
Time frame: 36 months total
We will tangentially perform a qualitative review of the patient's pre and post-operatively using the validated Breast-Q questionnaire. The BREAST-Q module for women who undergo breast augmentation is a rigorously developed PROM that is comprised of 9 independently functioning scales. It has undergone extensive psychometric evaluation and its developers report that it may be used like interval-scale data. Scores from these instruments are scaled to range from 0 to 100. This study will be conducted at affiliated clinical sites in London, Ontario.
1 secondary outcome
3. Does one method of fat processing have a reduced rate of short, or long term complications?
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: Undecided. This is an ongoing discussion. At present there is a slight lean towards not making individual participant data available. This is to protect patient information during inclusion in this trial.
Related trials for Breast Asymmetry
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RecruitingObservational study
Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)
Breast Cancer, Breast Carcinoma in Situ
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.
Khalifa AlGhanim, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Fat grafting - Revolve device and Fat grafting - Decantation in people with Breast Asymmetry and Fat Atrophy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 2 inclusion and 3 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Tanya DeLyzer, BSc MD FRCSC (519.685.8108, carrie.deer@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. What is the volume of fat retained between the two most common methods of fat processing? (time frame: 12 months recruitment and 24 months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2022.