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Single-arm multicenter interventional clinical trial of buttock augmentation with polymethyl methacrylate.
The objective is to evaluate the safety and effectiveness of using 30% Biosimetric PMMA gel for buttock augmentation.
The sample will be 133 patients. Specific patients will be screened at study sites according to eligibility classifications. After signing the consent form, patients will be included in the study and will be monitored for 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | PMMA (polymethylmethacrylate) 30% Biosimetric |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMMA | Device | PMMA 30% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by clinical evaluation | Occurrence of adverse events in patients who underwent gluteal augmentation with 30% Biosymmetric PMMA. Expected events will be classified as adverse events when they persist for more than two weeks, and should be reported throughout the study. Adverse events not previously identified will also be monitored at all visits. | Before application of PMMA and 6 and 9 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in normal values of laboratory biochemical tests | laboratory biochemical exams | Before application of PMMA and 6 and 9 months after the procedure |
| Volumetric capacity of filled muscle assessed by ultrasound imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos P Cunha | Contact | +55 981120522 | mtcmedical@hotmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20871994 | Background | Nicareta B, Pereira LH, Sterodimas A, Illouz YG. Autologous gluteal lipograft. Aesthetic Plast Surg. 2011 Apr;35(2):216-24. doi: 10.1007/s00266-010-9590-y. Epub 2010 Sep 25. | |
| 20885205 | Background | Talbot SG, Parrett BM, Yaremchuk MJ. Sepsis after autologous fat grafting. Plast Reconstr Surg. 2010 Oct;126(4):162e-164e. doi: 10.1097/PRS.0b013e3181ea4541. |
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Using an ultrasound device, images of the gluteus will be obtained to analyze the thickness of the muscle, and thus estimate its volumetric capacity.
| Before application of PMMA and 6 and 9 months after the procedure |
| Physician satisfaction assessed by GAIS scale | Physician satisfaction will be assessed using the Portuguese version of the Global Aesthetic Improvement Scale, assigning values according to the following parameters: Much improved (5): excellent cosmetic result after the procedure. Much improved (4): marked improvement in appearance from the initial condition, but not completely optimal for the patient. Better (3): obvious improvement in appearance from the initial condition. Unchanged (2): appearance is essentially the same as the original condition. Worse (1): appearance is worse than the original condition. | Before application of PMMA and 4, 6 and 9 months after the procedure |
| Patient satisfaction assessed by GAIS scale | Patient satisfaction will be assessed using the Portuguese version of the Global Aesthetic Improvement Scale, assigning values according to the following parameters: Much improved (5): excellent cosmetic result after the procedure. Much improved (4): marked improvement in appearance from the initial condition, but not completely optimal for the patient. Better (3): obvious improvement in appearance from the initial condition. Unchanged (2): appearance is essentially the same as the original condition. Worse (1): appearance is worse than the original condition. | Up to 4, 6 and 9 months after the procedure |
| 37241146 | Background | Stojicic M, Jurisic M, Marinkovic M, Jovanovic M, Igic A, Nikolic Zivanovic M. Necrotizing Skin and Soft Tissue Infection after Gluteal Augmentation in a Perioperatively Asymptomatic COVID-19 Patient-Complications of the Post-Lockdown Era? A Case Report. Medicina (Kaunas). 2023 May 10;59(5):914. doi: 10.3390/medicina59050914. |
| 38580866 | Background | Guzey S, Ergan Sahin A. Brazilian Butt Lift: An Experience Over 3000 Patients. Aesthetic Plast Surg. 2024 Jul;48(14):2677-2693. doi: 10.1007/s00266-024-03965-8. Epub 2024 Apr 5. |