The Fat Analysis Trial (FAT) - Assessing the Impact of Lipo-aspirate Processing

NCT05318716 | Unknown FDA Device

• 1 other identifier: 11811
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Breast Asymmetry; Fat Atrophy

Keywords

Fat grafting; Fat survival; Breast surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  36 months total

Secondary Outcomes (1)

• 3. Does one method of fat processing have a reduced rate of short, or long term complications?

  36 months

Other Outcomes (1)

• Is the grafted fat incorporated better between the two methods?

  3 months

Study Arms (2)

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.

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.

Device: Fat grafting - Revolve device; Device: Fat grafting - Decantation

Interventions

Fat grafting - Revolve device DEVICE

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.

Cosmetic augmentation group; Reconstructive group

Fat grafting - Decantation DEVICE

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.

Cosmetic augmentation group; Reconstructive group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous fat grafting
• Autologous breast reconstruction (regional or free flap)
• unable to consent to the study

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Conditions

Anisomastia

Central Study Contacts

Tanya DeLyzer, BSc MD FRCSC

CONTACT

519.685.8108; carrie.deer@lhsc.on.ca

Khalifa AlGhanim, MD

CONTACT

khalifa.alghanim@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: When the patients check in at the reception desk, they will be assigned a ticket with a 0 or 1 sequentially. This will be placed in their file. Group 0 patients will receive Decantation, and group 1 will receive Revolve. The nurse will collect this ticket, along with the patient's registration documents to prepare the equipment. Photography will be done by a research assistant/coordinator. The person will be responsible for imaging patients, as well as conducting the volume analysis following training by the software manufacturer. This person will be blinded to which method is used. During subsequent follow ups, the patient will have a 0 or 1 in their chart, to accurately collect data while in follow up. The surgeon, assistants and nurses will not be able to be blinded as they are the person responsible for using the device in the operating room.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Plastic and Reconstructive Surgery

Model Details: Prospective randomized controlled trial, we aim to recruit patients already scheduled to undergo fat grafting to the breast for reconstruction or cosmetic augmentation.

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 8, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2025
• Last Updated: April 8, 2022

Record last verified: 2022-04