Autologous Fat Grafting Techniques in Patients Undergoing Reconstructive Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/31/2018 |
| Start Date: | February 4, 2016 |
| End Date: | February 1, 2019 |
A Randomized, Prospective Comparison of Time Associated With Techniques to Process Autologous Fat Grafts
This randomized clinical trial studies and compares 3 techniques in performing autologous fat
grafting (AFG) in patients undergoing surgery to reshape or rebuild (reconstruct) a part of
the body changed by previous surgery and inserted into another part of the body. AFG, also
called fat injections or fat transplant, is a procedure in which an individual's own body fat
(usually from abdomen or legs) is used during reconstructive surgery. Doctors want to compare
3 techniques for processing the fat tissue collected during surgery and the length of time
needed to complete each AFG technique and surgery. Comparing 3 AFG techniques and the time to
complete them during surgery may help doctors determine the best technique to perform fat
grafting in the future.
grafting (AFG) in patients undergoing surgery to reshape or rebuild (reconstruct) a part of
the body changed by previous surgery and inserted into another part of the body. AFG, also
called fat injections or fat transplant, is a procedure in which an individual's own body fat
(usually from abdomen or legs) is used during reconstructive surgery. Doctors want to compare
3 techniques for processing the fat tissue collected during surgery and the length of time
needed to complete each AFG technique and surgery. Comparing 3 AFG techniques and the time to
complete them during surgery may help doctors determine the best technique to perform fat
grafting in the future.
PRIMARY OBJECTIVES:
I. Measure and compare the rate of fat processed, defined as the volume of fat processed per
unit time associated with the use of three aforementioned adipose tissue processing
techniques.
SECONDARY OBJECTIVES:
I. To measure total fat grafting time: time from initiation of fat harvesting to the end of
fat injection.
II. To measure volume of fat processed: volume of fat obtained after fat processing.
III. To measure total operation room (OR) time: time from patient entry into the OR (or when
the patient barcode is read on entering the OR) to the time at which the patient leaves the
OR.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (REVOLVE TM): Patients undergo AFG reconstructive surgery comprising washing and low
velocity spinning using a commercially available system that washes the lipoaspirate with
lactated Ringer's solution separates non-fat material from the fat with gentle centrifugal
force and suction.
ARM II (CYTORI PUREGRAT TM): Patients undergo AFG reconstructive surgery comprising gravity
filtration using a commercially available system in which the lipoaspirate is rinsed with
lactated Ringer's solution (RL) and the non-fat material is filtered through mesh.
ARM III (COLEMAN TECHNIQUE): Patients undergo AFG reconstructive surgery comprising standard
centrifugation at 3200 revolutions per minute (rpm) for 3 minutes with the resulting oil and
aqueous layers discarded.
I. Measure and compare the rate of fat processed, defined as the volume of fat processed per
unit time associated with the use of three aforementioned adipose tissue processing
techniques.
SECONDARY OBJECTIVES:
I. To measure total fat grafting time: time from initiation of fat harvesting to the end of
fat injection.
II. To measure volume of fat processed: volume of fat obtained after fat processing.
III. To measure total operation room (OR) time: time from patient entry into the OR (or when
the patient barcode is read on entering the OR) to the time at which the patient leaves the
OR.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (REVOLVE TM): Patients undergo AFG reconstructive surgery comprising washing and low
velocity spinning using a commercially available system that washes the lipoaspirate with
lactated Ringer's solution separates non-fat material from the fat with gentle centrifugal
force and suction.
ARM II (CYTORI PUREGRAT TM): Patients undergo AFG reconstructive surgery comprising gravity
filtration using a commercially available system in which the lipoaspirate is rinsed with
lactated Ringer's solution (RL) and the non-fat material is filtered through mesh.
ARM III (COLEMAN TECHNIQUE): Patients undergo AFG reconstructive surgery comprising standard
centrifugation at 3200 revolutions per minute (rpm) for 3 minutes with the resulting oil and
aqueous layers discarded.
Inclusion Criteria:
- Patients with available harvest sites for fat grafting
- Patients with body mass index (BMI) > 20
- Estimated harvested fat volume >= 100 cc
- Patients are willing and able to give consent
Exclusion Criteria:
- Patients with active cancer, including primary cancer, recurrent cancer, or locally or
distant metastasis
- Patients who are unable to provide consent
- Patients who are suspected or known to be pregnant
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