Health Status UnknownNCT02677012
Autologous Fat Grafting Techniques in Patients Undergoing Reconstructive Surgery
An observational study of Health Status Unknown, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Status Unknown
- What is being tested?
- Autologous Fat Graft and Reconstructive Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2016to 3 Jul 2020
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Health Status Unknown
- Being tested
- Autologous Fat Graft, Reconstructive Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fat GraftProcedure or surgery
Also called Autologous Fat Cell Transplantation, Autologous Fat Injection, Autologous Fat Transfer
Undergo AFG using the RESOLVE TM technique
Autologous Fat GraftProcedure or surgery
Also called Autologous Fat Cell Transplantation, Autologous Fat Injection, Autologous Fat Transfer
Undergo AFG using the Cytori PureGraft TM technique
Autologous Fat GraftProcedure or surgery
Also called Autologous Fat Cell Transplantation, Autologous Fat Injection, Autologous Fat Transfer
Undergo AFG using the Coleman technique
Reconstructive SurgeryProcedure or surgery
Also called Reconstruction
Undergo reconstructive surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm I (RESOLVE 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. Receives: Procedure: Autologous Fat Graft; Procedure: Reconstructive Surgery | |
| Arm II (Cytori PureGraft TM) | Patients undergo AFG reconstructive surgery comprising gravity filtration using a commercially available system in which the lipoaspirate is rinsed with lactated RL and the non-fat material is filtered through mesh. Receives: Procedure: Autologous Fat Graft; Procedure: Reconstructive Surgery | |
| Arm III (Coleman technique) | Patients undergo AFG reconstructive surgery comprising standard centrifugation at 3200 rpm for 3 minutes with the resulting oil and aqueous layers discarded. Receives: Procedure: Autologous Fat Graft; Procedure: Reconstructive Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fat processed defined as the volume of fat harvested per minute
Study data will be collected and managed using the Research Electronic Data Capture. This study will measure and compare the rate of fat processed, defined as the volume of fat processed per unit time associated with the use of three adipose tissue processing techniques.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start4 Feb 2016
- Primary completion3 Jul 2020
- Study completion3 Jul 2020
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 Health Status UnknownStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Summer Hanson, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677012
- Sponsor's protocol ID
- 2015-0006
- Other IDs
- NCI-2016-00346, 2015-0006, P30CA016672
- Status last verified
- Jul 2020
- First submitted
- 4 Feb 2016
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hanson SE, Garvey PB, Chang EI, Reece GP, Liu J, Baumann DP, Butler CE. A Randomized Prospective Time and Motion Comparison of Techniques to Process Autologous Fat Grafts. Plast Reconstr Surg. 2021 May 1;147(5):1035-1044. doi: 10.1097/PRS.0000000000007827.
PubMed 33890883
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Comparison of Time Associated With Techniques to Process Autologous Fat Grafts
- ClinicalTrials.gov ID
- NCT02677012
- Acronym / sponsor ID
- 2015-0006
- Conditions
- Health Status Unknown
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 9 Feb 2016 (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.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (RESOLVE TM) | – | Procedure: Autologous Fat Graft, Procedure: Reconstructive SurgeryPatients 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 PureGraft TM) | – | Procedure: Autologous Fat Graft, Procedure: Reconstructive SurgeryPatients undergo AFG reconstructive surgery comprising gravity filtration using a commercially available system in which the lipoaspirate is rinsed with lactated RL and the non-fat material is filtered through mesh. |
| Arm III (Coleman technique) | – | Procedure: Autologous Fat Graft, Procedure: Reconstructive SurgeryPatients undergo AFG reconstructive surgery comprising standard centrifugation at 3200 rpm for 3 minutes with the resulting oil and aqueous layers discarded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 GraftAlso: Autologous Fat Cell Transplantation, Autologous Fat Injection, Autologous Fat TransferUndergo AFG using the RESOLVE TM technique | Procedure or surgery | Arm I (RESOLVE TM) |
| Autologous Fat GraftAlso: Autologous Fat Cell Transplantation, Autologous Fat Injection, Autologous Fat TransferUndergo AFG using the Cytori PureGraft TM technique | Procedure or surgery | Arm II (Cytori PureGraft TM) |
| Autologous Fat GraftAlso: Autologous Fat Cell Transplantation, Autologous Fat Injection, Autologous Fat TransferUndergo AFG using the Coleman technique | Procedure or surgery | Arm III (Coleman technique) |
| Reconstructive SurgeryAlso: ReconstructionUndergo reconstructive surgery | Procedure or surgery | Arm I (RESOLVE TM), Arm II (Cytori PureGraft TM), Arm III (Coleman technique) |
Primary outcome
Rate of fat processed defined as the volume of fat harvested per minute
Time frame: 1 day
Study data will be collected and managed using the Research Electronic Data Capture. This study will measure and compare the rate of fat processed, defined as the volume of fat processed per unit time associated with the use of three adipose tissue processing techniques.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 33890883Hanson SE, Garvey PB, Chang EI, Reece GP, Liu J, Baumann DP, Butler CE. A Randomized Prospective Time and Motion Comparison of Techniques to Process Autologous Fat Grafts. Plast Reconstr Surg. 2021 May 1;147(5):1035-1044. doi: 10.1097/PRS.0000000000007827.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Health Status Unknown
Active, not recruiting
Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome
Conditions Influencing Health Status, Healthy
Active, not recruiting
Patients Navigators in Facilitating Weight Management in Obese Participants
Health Status Unknown, Obesity
Active, not recruiting
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
Body Mass Index 25 or Greater, BRCA1 Gene Mutation
Active, not recruiting
Your Health Matters! (Tu Salud ¡Si Cuenta!): Promoting Healthy Lifestyles in Latino Families
Family Member, Health Status Unknown
Active, not recruiting
Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
Health Status Unknown, Elevated PSA
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.
Summer Hanson principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Status Unknown, run by M.D. Anderson Cancer Center at 1 site 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 4 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: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of fat processed defined as the volume of fat harvested per minute (time frame: 1 day). 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 NCT02677012, 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 14 Jul 2020.