Breast Reconstruction, Contour Irregularities, Volume Insufficiency
Conditions
Keywords
adipocytes, cell transplantations, mesenchymal stem cell, immunophenotyping, adipose tissue, breast reconstruction, mammaplasty, magnetic resonance imaging, fat necrosis
Brief summary
The purpose of this study is to investigate if there is a relationship between the take of fat grafts with and without ADSCs and the presence of specific surface markers on the cells of the stromal vascular fraction.
Detailed description
Two groups of patients will be studied. The control will receive centrifuged fat grafts while the other group will receive centrifuged enriched fat grafts with ADSCs. The performance of both grafts will be assessed through volume measurement employing MRI before and after 6 months post-op.
Interventions
GENETICcentrifuged fat graft
fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group.
GENETICADSCs enriched fat graft
fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* contour irregularities and volume insufficiency in reconstructed breasts no matter the method of reconstruction employed * local flaps with conditions to receive fat grafts * good health condition
Exclusion criteria
* breast cancer patients under chemotherapy * smokers * bad health condition * patients too thin * patients that require a new reconstructive surgery (secondary reconstruction)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume Maintenance | up to 1 year | Volumetry of the reconstructed breasts will be accomplished through MRI and OsiriX software. Osirix software allows breast volume calculation through the determination of regions of interest (ROIs) on an MRI sequence. Once the pre (V1) and postoperative (V2) volumes were determined the following formula was applied: (V2 - V1) X 100/graft volume. The result, expressed in percentage, expresses graft volume persistence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunophenotyping | baseline | Immunophenotyping of the fresh stromal vascular fraction of both groups. Immunophenotyping or flow cytometry measures how many cells, in a sample, express a specific surface marker. A surface marker or a group of markers may characterize a specific cell type. The software that accompanies the flow cytometer determines the number of cells (in percentage) that express the tested surface marker. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Fat Necrosis in the Postoperative Period | up to 3 years | Fat necrosis may occur whenever a fat graft is performed and it has clinical relevance. It can emerge as oil cysts or small nodules a little bit painful. In mammograms of normal breasts, fat necrosis present as cysts or micro calcifications that present a benign appearance. In breast reconstruction patients, fat necrosis, despite its benign characteristics, can suggest cancer recurrence. |
Countries
Brazil
Participant flow
Recruitment details
patients who have contour irregularities after any method of breast reconstruction. recruited from jan/2012 to august/2014.
Participants by arm
| Arm | Count |
|---|---|
| Centrifuged Fat Graft female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group. | 8 |
| ADSCs Enriched Centrifuged Fat Graft female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement
ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts. | 11 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Centrifuged Fat Graft | ADSCs Enriched Centrifuged Fat Graft | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 11 Participants | 18 Participants |
| Age, Continuous | 49.8 years STANDARD_DEVIATION 11.5 | 49.6 years STANDARD_DEVIATION 5.7 | 49.7 years STANDARD_DEVIATION 8.3 |
| breast volume | 562.8 mL STANDARD_DEVIATION 187.7 | 650.1 mL STANDARD_DEVIATION 206.8 | 613.3 mL STANDARD_DEVIATION 198.5 |
| Region of Enrollment Brazil | 8 participants | 11 participants | 19 participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 11 |
| serious Total, serious adverse events | 0 / 8 | 0 / 11 |
Outcome results
Primary
Volume Maintenance
Volumetry of the reconstructed breasts will be accomplished through MRI and OsiriX software. Osirix software allows breast volume calculation through the determination of regions of interest (ROIs) on an MRI sequence. Once the pre (V1) and postoperative (V2) volumes were determined the following formula was applied: (V2 - V1) X 100/graft volume. The result, expressed in percentage, expresses graft volume persistence.
Time frame: up to 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Centrifuged Fat Graft | Volume Maintenance | 51.6 percentage of graft volume persistency | Standard Deviation 18.4 |
| ADSCs Enriched Centrifuged Fat Graft | Volume Maintenance | 78.9 percentage of graft volume persistency | Standard Deviation 74.9 |
p-value: 0.31Wilcoxon (Mann-Whitney)
Secondary
Immunophenotyping
Immunophenotyping of the fresh stromal vascular fraction of both groups. Immunophenotyping or flow cytometry measures how many cells, in a sample, express a specific surface marker. A surface marker or a group of markers may characterize a specific cell type. The software that accompanies the flow cytometer determines the number of cells (in percentage) that express the tested surface marker.
Time frame: baseline
Population: we had technical problems in processing 4 tissue samples in each arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Centrifuged Fat Graft | Immunophenotyping | 27 percentage of expression for CD90 | Standard Deviation 27.9 |
| ADSCs Enriched Centrifuged Fat Graft | Immunophenotyping | 79 percentage of expression for CD90 | Standard Deviation 15.4 |
p-value: 0.026Wilcoxon (Mann-Whitney)
Other Pre-specified
Number of Participants Experiencing Fat Necrosis in the Postoperative Period
Fat necrosis may occur whenever a fat graft is performed and it has clinical relevance. It can emerge as oil cysts or small nodules a little bit painful. In mammograms of normal breasts, fat necrosis present as cysts or micro calcifications that present a benign appearance. In breast reconstruction patients, fat necrosis, despite its benign characteristics, can suggest cancer recurrence.
Time frame: up to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Centrifuged Fat Graft | Number of Participants Experiencing Fat Necrosis in the Postoperative Period | 0 participants |
| ADSCs Enriched Centrifuged Fat Graft | Number of Participants Experiencing Fat Necrosis in the Postoperative Period | 4 participants |
p-value: 0.103Fisher Exact