Mammoplasty PatientNCT03502512
REVOLVE or PureGraft Technique in Processing Fat Grafts for Patients Undergoing Breast Reconstruction
A study testing Questionnaire Administration and Reconstructive Surgery in people with Mammoplasty Patient, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well REVOLVE or PureGraft technique works in processing fat grafts for patients who are undergoing breast reconstruction. During breast reconstructive surgery that uses autologous fat grafting (transplanting fat tissue from one part of your body to another), fat tissue is removed from the body… 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
- Mammoplasty Patient
- What is being tested?
- Questionnaire Administration and Reconstructive Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2018to 6 Aug 2021
- 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
- Previous breast surgery, either mastectomy or partial mastectomy
- Patients with available harvest sites for fat grafting
- Patients with body mass index (BMI) > 20
- Anticipated 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 and locally or distantly metastatic cancer
- 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 Methods to Process Autologous Fat Grafts in Breast Reconstruction
This trial studies how well REVOLVE or PureGraft technique works in processing fat grafts for patients who are undergoing breast reconstruction. During breast reconstructive surgery that uses autologous fat grafting (transplanting fat tissue from one part of your body to another), fat tissue is removed from the body (usually the abdomen, buttock, or thighs) and injected into another part of the body. This tissue must be "processed" (sometimes referred to as "washed" or "prepared") before being inserted back into the body. It is not yet known whether REVOLVE or PureGraft technique may work better in retaining graft fat after surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- To measure and compare the rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of two aforementioned adipose tissue processing techniques.
SECONDARY OBJECTIVES:
- To measure early post-operative complications including infection, hematoma, delayed wound healing or seroma.
II. To measure late complications associated with fat grafting including fat necrosis, cyst formation, palpable mass, or breast asymmetry.
III. To measure patient reported outcomes (PRO, BREAST-Questionnaire [Q], Body Image Survey).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo reconstructive surgery with REVOLVE technique.
ARM II: Patients undergo reconstructive surgery with PureGraft technique.
After completion of study, patients are followed up at 2-4 weeks and then once a year for up to 2 years.
- Conditions
- Mammoplasty Patient
- Being tested
- Questionnaire Administration, Reconstructive Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Ancillary studies
Reconstructive SurgeryProcedure or surgery
Also called Reconstruction
Undergo reconstructive surgery with REVOLVE technique
Reconstructive SurgeryProcedure or surgery
Also called Reconstruction
Undergo reconstructive surgery with PureGraft technique
| Study group | Role | What they receive |
|---|---|---|
| Arm I (REVOLVE technique) | Experimental | Patients undergo reconstructive surgery with REVOLVE technique. Receives: Other: Questionnaire Administration; Procedure: Reconstructive Surgery |
| Arm II (PureGraft technique) | Experimental | Patients undergo reconstructive surgery with PureGraft technique. Receives: Other: Questionnaire Administration; Procedure: Reconstructive Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat graft retention rate
Rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of the REVOLVE and PureGraft tissue processing techniques.
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start13 Feb 2018
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammoplasty PatientStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Reece, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502512
- Sponsor's protocol ID
- 2016-0463
- Other IDs
- NCI-2018-00944, 2016-0463
- Status last verified
- Aug 2021
- First submitted
- 11 Apr 2018
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Comparison of Methods to Process Autologous Fat Grafts in Breast Reconstruction
- ClinicalTrials.gov ID
- NCT03502512
- Acronym / sponsor ID
- 2016-0463
- Conditions
- Mammoplasty Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 18 Apr 2018 (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.
This trial studies how well REVOLVE or PureGraft technique works in processing fat grafts for patients who are undergoing breast reconstruction. During breast reconstructive surgery that uses autologous fat grafting (transplanting fat tissue from one part of your body to another), fat tissue is removed from the body (usually the abdomen, buttock, or thighs) and injected into another part of the body. This tissue must be "processed" (sometimes referred to as "washed" or "prepared") before being inserted back into the body. It is not yet known whether REVOLVE or PureGraft technique may work better in retaining graft fat after surgery.
Detailed description
PRIMARY OBJECTIVES:
- To measure and compare the rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of two aforementioned adipose tissue processing techniques.
SECONDARY OBJECTIVES:
- To measure early post-operative complications including infection, hematoma, delayed wound healing or seroma.
II. To measure late complications associated with fat grafting including fat necrosis, cyst formation, palpable mass, or breast asymmetry.
III. To measure patient reported outcomes (PRO, BREAST-Questionnaire [Q], Body Image Survey).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo reconstructive surgery with REVOLVE technique.
ARM II: Patients undergo reconstructive surgery with PureGraft technique.
After completion of study, patients are followed up at 2-4 weeks and then once a year for up to 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (REVOLVE technique) | Experimental | Other: Questionnaire Administration, Procedure: Reconstructive SurgeryPatients undergo reconstructive surgery with REVOLVE technique. |
| Arm II (PureGraft technique) | Experimental | Other: Questionnaire Administration, Procedure: Reconstructive SurgeryPatients undergo reconstructive surgery with PureGraft technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previous breast surgery, either mastectomy or partial mastectomy
- Patients with available harvest sites for fat grafting
- Patients with body mass index (BMI) > 20
- Anticipated 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 and locally or distantly metastatic cancer
- 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 |
|---|---|---|
| Questionnaire AdministrationAncillary studies | Other | Arm I (REVOLVE technique), Arm II (PureGraft technique) |
| Reconstructive SurgeryAlso: ReconstructionUndergo reconstructive surgery with REVOLVE technique | Procedure or surgery | Arm I (REVOLVE technique) |
| Reconstructive SurgeryAlso: ReconstructionUndergo reconstructive surgery with PureGraft technique | Procedure or surgery | Arm II (PureGraft technique) |
Primary outcome
Fat graft retention rate
Time frame: At 1 year
Rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of the REVOLVE and PureGraft 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 17 Aug 2021.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Gregory Reece, MD 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?
A study testing Questionnaire Administration and Reconstructive Surgery in people with Mammoplasty Patient, 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 5 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 17 Aug 2021. 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?
Fat graft retention rate (time frame: At 1 year). 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 17 Aug 2021; AzTrials last refreshed its copy on 4 Nov 2026.