Clinical trial NCT06544304: Buttock Augmentation With Polymethylmethacrylate
Official title: Interventional, Multicenter, Single-Arm Clinical Trial of Buttock Augmentation With Polymethylmethacrylate
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Aesthetics
Augmentation
Keywords: augmentation
gluteal
Lead sponsor: MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60 years old;
* Signed Informed Consent Form (ICF);
* Participant understands and is willing to participate in the clinical study and attend visits.

Exclusion Criteria:

* Known history of allergy to formula components;
* Have the following morbidities (or any other disease that may interfere with the study): chronic inflammatory disease, immunosuppression, diabetes, hypertension, autoimmune disease, dermatological disease in the region to be treated, acute or chronic renal failure, history of coronary disease, history of cerebrovascular disease, current neoplasia, mental illness undergoing psychiatric treatment, obesity with a BMI above 30, asthma, bronchitis, seizures, hepatitis or other active infectious diseases;
* Pregnancy;
* Prior filling of glutes;
* Use of acetylsalicylic acid, anti-inflammatories, anticoagulants, in the fifteen days before the procedure.
* Vitamin D supplementation, with normal serum levels and which you do not agree to suspend;
* Use of anabolic hormones;
* Vitamin D (25 hydroxyvitamin D) greater than 70 ng/mL;
* Serum calcium greater than 10 mg/dL;
* Patients with total body PMMA volume of 650mL or more.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by clinical evaluation
timeFrame: Before application of PMMA and 6 and 9 months after the procedure
Secondary outcomes:
measure: Changes in normal values of laboratory biochemical tests
timeFrame: Before application of PMMA and 6 and 9 months after the procedure
measure: Volumetric capacity of filled muscle assessed by ultrasound imaging
timeFrame: Before application of PMMA and 6 and 9 months after the procedure
measure: Physician satisfaction assessed by GAIS scale
timeFrame: Before application of PMMA and 4, 6 and 9 months after the procedure
measure: Patient satisfaction assessed by GAIS scale
timeFrame: Up to 4, 6 and 9 months after the procedure
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.