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1.
Rev. colomb. cir ; 39(5): 787-792, Septiembre 16, 2024. fig
Artigo em Espanhol | LILACS | ID: biblio-1571937

RESUMO

Introducción. La gangrena de Fournier es un proceso infeccioso progresivo que compromete piel, tejido celular subcutáneo, grasa y fascia subyacente, con una incidencia de 1,6 pacientes por cada 100.000 personas/año. Se considera una urgencia quirúrgica, que requiere de manejo oportuno, ya que puede llegar a ser fatal, con una tasa de mortalidad del 20 al 35 %, que es más alta en hombres, en la tercera década de la vida y en pacientes inmunocomprometidos. Caso clínico. Se presenta el caso clínico de un paciente masculino de 44 años de edad, quien cursó con gangrena de Fournier secundaria a una espina de pescado de 5 cm de largo, incrustada en la unión anorrectal. Resultados. El paciente fue manejado por urología y cirugía general, requirió hospitalización en la Unidad de Cuidados Intensivos y curaciones por parte de terapia enterostomal, con resultados satisfactorios. Conclusiones. Sus posibles causas son múltiples y en ocasiones puede ser desencadenada por un factor externo, como un cuerpo extraño. Uno de los factores predisponentes es la obesidad. El diagnóstico oportuno y un tratamiento con intervención multidisciplinaria mejoran la sobrevida y la calidad de vida de los pacientes.


Introduction. Fournier's gangrene is a progressive infectious process that involves skin, subcutaneous tissue, fat and underlying fascia, with an incidence of 1.6 per 100,000 people/year. It is considered a surgical emergency, which requires timely management since it can be fatal, with a mortality rate of 20 to 35%, which is higher in men, in the third decade of life and in immunocompromised patients. Clinical case. Clinical case. A 44-year-old male patient is presented with Fournier's gangrene secondary to a 5 cm long fishbone embedded in the anorectal junction. Results. The patient was managed by urology and general surgery, requiring hospitalization in the ICU and treated by enterostomal therapy with satisfactory results. Conclusions. Its possible causes are multiple and sometimes it can be triggered by an external factor, such as a foreign body. One of the predisposing factors is obesity. Timely diagnosis and treatment with multidisciplinary intervention improve survival and quality of life of patients


Assuntos
Humanos , Sistema Urogenital , Gangrena de Fournier , Reto , Fasciite Necrosante , Celulite
2.
Dermatol Surg ; 50(10): 922-925, 2024 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-38754134

RESUMO

BACKGROUND: Ultrasound energy can successfully treat fine lines and wrinkles, as well as lift the eyebrow and submentum. Ultrasound waves of high intensity induce thermal injury in the dermis with subsequent tissue remodeling. OBJECTIVE: To examine the utility of a novel ultrasound device that utilizes high-intensity, high-frequency, parallel ultrasound beams to improve the clinical appearance of cellulite on the thighs and buttocks. MATERIALS AND METHODS: A prospective, multicenter, clinical study investigated this novel ultrasound device using 2 treatments. RESULTS: Sixty-five subjects completed both treatments. The mean age was 46 years, and 100% were women. Fitzpatrick skin types I to VI were represented. Assessments compared 3-month follow-up with baseline. Two blinded reviewers agreed in identifying pretreatment and post-treatment photographs for 89.2%. For Cellulite Severity Scale rating, there was significant improvement of 1.61 units ( p < .001). For cellulite Global Aesthetic Improvement Scale (GAIS), 89.2% had improvement, with a mean of 0.87 units ( p < .001). For Laxity Scale rating, there was significant improvement of 0.70 units ( p < .001). For skin laxity GAIS, 89.2% had improvement, with a mean of 0.76 units ( p < .001). No device-related adverse events occurred. CONCLUSION: A novel ultrasound device that utilizes high-intensity, high-frequency, parallel ultrasound beams can safely and effectively improve the clinical appearance of cellulite on the thighs and buttocks.


Assuntos
Celulite , Coxa da Perna , Terapia por Ultrassom , Humanos , Feminino , Nádegas , Celulite/radioterapia , Pessoa de Meia-Idade , Estudos Prospectivos , Masculino , Terapia por Ultrassom/métodos , Terapia por Ultrassom/instrumentação , Adulto , Técnicas Cosméticas/instrumentação , Resultado do Tratamento , Idoso
3.
J Cosmet Dermatol ; 23(8): 2581-2591, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38571374

RESUMO

BACKGROUND: With the rise in interest and demand for body contouring, beauty devices have continuously developed. Suction can aid in increasing the rate of fat breakdown by inducing a massage-like effect, thereby increasing blood flow. Moreover, radiofrequency (RF) can boost fibroblast activity and help reduce cellulite. In addition, electrical muscle stimulation (EMS) can use electrical stimulation to induce muscle contraction, leading to an athletic, and skin elasticity-increasing effect. AIMS: This study aimed to assess the effects of body contouring, such as cellulite and swelling, in healthy Korean women to objectively prove the efficacy of an at-home beauty device equipped with suction, RF, and EMS functions. METHODS: For 8 weeks, 21 participants used the at-home beauty device 3 days a week on their abdomen, thighs, and left calf. Validity assessments and subjective surveys were conducted at 4 and 8 weeks, including the first visit. RESULTS: The results of the validity assessments revealed that cellulite, swelling, elasticity, femoral skin texture, and dermal density were significantly (p < 0.05) improved in the experimental group compared with those at the baseline. CONCLUSIONS: The results of this study demonstrate that the combination of suction, RF, and EMS function is effective for body skin, fat, and body shape management. For better body-contouring effects, combining the beauty device with regular exercise and healthy eating habits is recommended.


Assuntos
Contorno Corporal , Humanos , Feminino , Contorno Corporal/métodos , Contorno Corporal/instrumentação , Adulto , Sucção/instrumentação , Elasticidade/efeitos da radiação , Celulite/terapia , Coxa da Perna , Terapia por Estimulação Elétrica/instrumentação , Terapia por Estimulação Elétrica/métodos , Perna (Membro) , Adulto Jovem , Terapia por Radiofrequência/instrumentação , Pele/efeitos da radiação , Edema/etiologia , Edema/prevenção & controle , República da Coreia
4.
Aesthetic Plast Surg ; 48(9): 1797-1806, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38253886

RESUMO

BACKGROUND: Cellulite is a condition characterized by dimpling and contour irregularities in the gluteal and thigh regions, affecting an estimated 80-98% of postpubertal women. Innovative treatments for cellulite dimpling in the buttocks have gained popularity in recent years, seeking new solutions for a historically challenging condition. In this open-label, investigator-initiated, single-center, prospective clinical study, the authors sought to evaluate the safety and efficacy of diluted calcium hydroxylapatite (CaHA; Radiesse®, Merz Aesthetics, Raleigh, NC) for the treatment of cellulite dimpling in the buttocks of adult women. METHODS: Subjects underwent three treatment sessions, receiving a total of 12 syringes of 1:1 diluted CaHA administered using a cannula-based subcision technique. Endpoints included the cellulite severity scale (CSS), the global aesthetic improvement scale (GAIS), subject satisfaction measured on a 5-point scale, and three-dimensional imaging analysis via the Quantificare 3D Track®. RESULTS: Twenty-four subjects completed the study (mean age, 35 years; mean BMI, 26.88 kg/m2; mean body fat percentage, 31.29%), and no serious complications were reported. Quantitative analysis at week 14 revealed a mean reduction of 54.0% in the number of visible dimples and 50.09% in dimple depth compared to baseline. The mean CSS score decreased by 4.29 points, representing a 43.92% improvement in cellulite severity from baseline (p < 0.0001). Both physician-assessed and subject-assessed GAIS ratings also demonstrated significant improvement, with 91.6% of subjects rating their cellulite appearance as "improved" or greater. CONCLUSION: The results of this study support the safety and efficacy of diluted CaHA for treating cellulite dimpling in adult women. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors   www.springer.com/00266 . CLINICAL TRIALS REGISTRATION: This study is registered with clinicaltrials.gov (ID: NCT05885035) and can be found at this link: https://clinicaltrials.gov/study/NCT05885035 .


Assuntos
Celulite , Durapatita , Humanos , Feminino , Celulite/tratamento farmacológico , Adulto , Estudos Prospectivos , Durapatita/administração & dosagem , Nádegas , Resultado do Tratamento , Estética , Satisfação do Paciente/estatística & dados numéricos , Pessoa de Meia-Idade , Técnicas Cosméticas , Adulto Jovem , Materiais Biocompatíveis
5.
Lasers Surg Med ; 56(1): 32-38, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37694399

RESUMO

BACKGROUND: A recent study showed the safety and efficacy of a noninvasive acoustic subcision device to improve the appearance of cellulite via delivery of rapid acoustic pulses in a single treatment visit. OBJECTIVE: To evaluate and compare the safety and efficacy of a single rapid acoustic pulse treatment visit using an equivalent number of rapid acoustic pulses at a pulse rate of 100 or 50 Hz. METHODS: This single-center, prospective study enrolled 15 adult women with moderate to severe cellulite according to the Cellulite Dimple-At Rest Scale. Each participant would receive nominally 72,000 rapid acoustic pulses at a pulse rate of 50 Hz on the left buttock and thigh, and nominally 72,000 rapid acoustic pulses at a pulse rate of 100 Hz on the right buttock and thigh within one treatment visit. Efficacy was assessed by the ability of blinded, independent reviewers to correctly distinguish the pre- and post-treatment photos, participant satisfaction, and the change in Cellulite Dimple-At Rest scores for each treatment side. Safety was monitored throughout the conduct of the study. RESULTS: For both 100 and 50 Hz pulse rate treated areas, the majority (two out of three) of blinded reviewers correctly identified 100% of the pre/post-treatment photos. For both the 100 and 50 Hz treated areas, 80% of participants agreed/strongly agreed that their cellulite appeared improved at the 12-week follow-up visit. Significant improvements in Cellulite Dimple-At Rest scores were seen for both the 100 and 50 Hz treated areas. All participants thought both the 100 and 50 Hz pulse rate treatments were tolerable, and the pain (mean score ± SD; 2.2 ± 1.2) associated with each was identical. No unexpected or serious adverse events occurred. CONCLUSION: Acoustic subcision delivered via rapid acoustic pulses at 100 Hz, compared to 50 Hz, provides equivalent improvement in the appearance of cellulite while maintaining a similar safety and efficacy profile. For both pulse rates, treatment pain was minimal, and participant satisfaction was high.


Assuntos
Celulite , Técnicas Cosméticas , Adulto , Humanos , Feminino , Frequência Cardíaca , Celulite/diagnóstico , Celulite/terapia , Estudos Prospectivos , Coxa da Perna , Dor , Resultado do Tratamento
7.
Dermatol Surg ; 50(2): 165-170, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38091485

RESUMO

BACKGROUND: Cellulite is an aesthetically displeasing rippling or dimpling of the skin, primarily on the buttocks/thighs. A recent study showed a novel acoustic subcision device produced significant short-term (12-week) improvement in the appearance of cellulite after a single rapid acoustic pulse (RAP) treatment. OBJECTIVE: To evaluate the long-term (>52-weeks) efficacy and safety of RAP treatment for improvement in the appearance of cellulite. MATERIALS AND METHODS: In this prospective, multicenter trial, female participants ( n = 42) with severe cellulite were treated with the acoustic subcision device in a single visit. At >52 weeks, blinded board-certified dermatologists assessed efficacy by correctly identifying post-treatment photographs and using a 6-point simplified Cellulite Severity Scale (CSS). Participant satisfaction was also collected. Safety was assessed throughout. RESULTS: The blinded panel correctly identified post-treatment photographs at a rate of 95.2%; 70.4% of participants had a >1-point reduction in the CSS score from baseline (mean reduction of 1.09). All participants (100%) reported improved cellulite appearance. Overall pain during treatment was rated as 2.4 and 0.3 post-treatment (pain scale 0-10). No device or treatment-related adverse events were reported at the >52-week follow-up. CONCLUSION: Rapid acoustic pulse treatment significantly improved the long-term appearance of cellulite and was well-tolerated.


Assuntos
Celulite , Técnicas Cosméticas , Humanos , Feminino , Satisfação do Paciente , Celulite/cirurgia , Estudos Prospectivos , Nádegas , Coxa da Perna , Acústica , Dor , Resultado do Tratamento
8.
Aesthetic Plast Surg ; 48(6): 1181-1192, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38110737

RESUMO

PURPOSE: To test the efficacy and safety of cross-linked hyaluronic acid application for filling buttocks and cellulite depressions and its permanence over time. METHODS: For a period of a year, 25 patients were applied redensified cross-linked hyaluronic acid in the gluteal area. These patients were all 23-45-year-old women with little fat to be removed. The product used is composed of hyaluronic acid with high cross-linking and redensification which allows it to maintain shape and durability over time. All patients underwent tumescent anesthesia with neuroleptic sedation in the operating room. The procedure was regarded as minimal (container, sterile gloves, and surgical field). The amount applied for gluteal augmentation varied from 50 to 100 ml per application area and according to the patient's needs. For the filling of cellulite depressions, the application was up to 3 cc per depression and up to a total of 40 ml. The maximum volume used per patient in the buttocks did not exceed 200 ml, and it did not exceed 40 ml in cellulite depressions. RESULTS: A group of patients was treated in the upper and middle third of the buttocks in superficial and deep subcutaneous layers and in cellulite depressions. Very good results have been obtained without any major complications. CONCLUSIONS: The use of redensified cross-linked hyaluronic acid of non-animal origin is therefore an option for gluteal augmentation and cellulite depressions. Although the product degrades over time, after 12 months, 44% of treated patients rated their results as highly or very much improved, 36% as improved, 16% rated the improvement as poor, and one patient (4%) was dissatisfied. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .


Assuntos
Celulite , Ácido Hialurônico , Humanos , Feminino , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Depressão , Nádegas/cirurgia , Resultado do Tratamento
10.
Aesthet Surg J ; 43(12): 1508-1520, 2023 11 16.
Artigo em Inglês | MEDLINE | ID: mdl-37184131

RESUMO

Cellulite in the proximal lower extremities is a reported concern among many adult females. The unsightly appearance of cellulite leads many affected individuals to seek treatment by trained specialists. The objective of this review is to provide the reader with an update on new and innovative therapies for cellulite including various treatment combinations to maximize therapeutic outcomes, and strategies for minimizing adverse events. The availability of new technologies and the results from recent clinical trials provide additional tools and data to consider when creating treatment plans for cellulite patients. This update to previous treatment recommendations is based on the most recent developments in cellulite management including the personal experiences of the authors with an emphasis on injectable enzymes, acoustic subcision, targeted verifiable subcision, and biostimulators. Formal clinical studies are warranted to compare various treatment modalities and further investigate combination regimens.


Assuntos
Celulite , Técnicas Cosméticas , Adulto , Feminino , Humanos , Celulite/terapia , Coxa da Perna , Nádegas
13.
Dermatol Surg ; 49(4S): S2-S7, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-37000912

RESUMO

BACKGROUND: Cellulite is a highly prevalent aesthetic condition in postpubertal women. OBJECTIVE: The objective of this article was to describe the latest data on the pathophysiology of cellulite and to highlight the psychosocial aspects that should be considered when treating cellulite. METHODS: A roundtable meeting was convened to discuss and share views on the latest data on the pathophysiology and psychosocial aspects of cellulite. The participants' experience helped guide a narrative review on this topic. RESULTS: The pathophysiology of cellulite primarily involves fibrous septal changes. Strategies targeting the fibrous septa have shown the most consistent efficacy, while showing inconsistent or short-term results when targeting the other components of cellulite, such as decreased dermal thickness, vascular alterations, and inflammation. Female sex, increased age, and high body mass index contribute to cellulite pathophysiology. CONCLUSION: Patients seeking treatment for cellulite are willing to endure numerous treatments, high cost, temporary and/or delayed results, and invasive procedures with potential adverse effects. Psychological discomfort has been reported among patients with cellulite, and understanding their behaviors and psychological characteristics can help clinicians provide better care to these patients seeking treatment.


Assuntos
Celulite , Humanos , Feminino , Celulite/terapia , Nádegas , Inflamação , Índice de Massa Corporal , Coxa da Perna , Tecido Adiposo
14.
Dermatol Surg ; 49(4S): S8-S14, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-37000913

RESUMO

BACKGROUND: Cellulite is a well-known concern for many women; however, treatment can prove challenging because of the complexities of cellulite etiology, the various factors contributing to its appearance, and the multitude of therapies and procedures available. OBJECTIVE: To discuss current cellulite treatment options and effective clinical management. METHODS: A roundtable meeting was convened to discuss and share views on current cellulite treatment options, new technologies, and clinical management. The participants' views helped guide a narrative review on this topic. RESULTS: Advanced interventions for cellulite treatment-such as physical and acoustic subcision, radiofrequency, and injectable biostimulators-are gradually being established, with accumulating evidence showing efficacy, patient satisfaction, and potentially long-lasting outcomes. Cellulite severity rating scales are necessary for assessing treatment outcomes, but these can be complex to use in clinical practice, and the majority do not include patient or clinician perspectives. CONCLUSION: With the advent of new treatments and technologies, cosmetic surgeons and dermatologists will need to tailor their approach to each patient's needs and manage patient expectations because multimodal methods are likely to be required to address the various factors underlying cellulite appearance.


Assuntos
Celulite , Técnicas Cosméticas , Cosméticos , Feminino , Humanos , Celulite/cirurgia , Resultado do Tratamento , Satisfação do Paciente , Coxa da Perna
15.
Dermatol Surg ; 49(4S): S15-S20, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-37000914

RESUMO

BACKGROUND: Existing cellulite interventions pose various clinical challenges related mostly to ecchymosis and recovery time. OBJECTIVE: To discuss the current treatment options for minimizing recovery time, efficacy of these options, and investigations into possible future approaches. METHODS: A roundtable meeting was convened to discuss and share views on the clinical challenges seen in the present practice of cellulite treatments along with future approaches and mitigation strategies. The participants' views helped guide a narrative review on this topic. RESULTS: Cosmetic clinicians have a range of new interventions to choose from for cellulite improvement, each with different benefits and safety aspects. Bruising is a typical side effect that is seen with treatments targeting the fibrous septa, such as subcision and injectable treatments, and in some cases may produce long-lasting hyperpigmentation from postinflammatory hyperpigmentation or hemosiderin staining. Various strategies that could potentially mitigate bruising and other adverse effects of cellulite treatment are under clinical investigation, including, but not limited to, different injection techniques and dilutions, compression garments, cold packs, arnica gel, pulsed dye laser treatment, intralesional epinephrine, and tranexamic acid. CONCLUSION: Clinical challenges including varying treatment outcomes and certain treatment sequelae remain, and further research is needed to prevent side effects and improve treatment outcomes.


Assuntos
Celulite , Contusões , Técnicas Cosméticas , Hiperpigmentação , Humanos , Celulite/cirurgia , Coxa da Perna , Resultado do Tratamento
17.
Dermatol Surg ; 49(4): 383-386, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-36826346

RESUMO

BACKGROUND: Collagenase clostridium histolyticum-aaes (CCH) is approved for the treatment of moderate-to-severe cellulite. OBJECTIVE: This is a retrospective image review of subjects previously enrolled in Cohort 2 of the EN3835-305 trial to determine the effects of CCH on volumetric changes of cellulite dimples and overall gluteal contouring. METHODS: In this retrospective analysis, photographs from Day 90 and Day 180 were superimposed on baseline images and the volumetric change of each treated cellulite dimple was quantified. Side-by-side photographs of the buttocks were also evaluated for change in gluteal contour using the Physician Global Aesthetic Improvement Scale (PGAIS). RESULTS: Fifty-eight female subjects and 403 cellulite dimples were evaluated. Three-dimensional imaging analysis revealed a significant improvement in total negative dimple volume at both Day 90 and Day 180 of 27% and 26%, respectively ( p < .001 and p = .002, respectively). At Day 90, the overall gluteal contour, as signified by the mean PGAIS among the 3 blinded dermatologists, was rated as +1 (improved) in 27% ( n = 17) of the subjects. At Day 180, the mean PGAIS was +1 (improved) or +2 (very much improved) in 39% ( n = 26) of the subjects. CONCLUSION: CHH is an effective tool for treating cellulite dimples and improving gluteal contour.


Assuntos
Celulite , Técnicas Cosméticas , Feminino , Humanos , Celulite/terapia , Injeções Intralesionais , Colagenase Microbiana , Estudos Retrospectivos , Coxa da Perna , Resultado do Tratamento
18.
Dermatol Surg ; 49(4): 378-382, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-36826378

RESUMO

BACKGROUND: More than 90% of women report concerns of cellulite on their skin. Poly- l lactic acid (PLLA-SCA) is a biocompatible, semipermanent, synthetic filler that induces neocollagenesis. OBJECTIVE: To investigate the safety and efficacy of PLLA-SCA for the treatment of cellulite of the buttock and thigh regions. METHODS: This was a prospective, single-center, double-blinded, split-body, clinical trial of 20 women with slight to moderate skin laxity of the buttocks and/or thighs contributing to mild-to-moderate cellulite. Each subject's buttocks and thighs were randomized to receive injections with up to 2 vials of PLLA-SCA or the equivalent volume of bacteriostatic water per treatment area. Subjects received at total of 3 treatments 4 weeks apart and were followed for 330 days. RESULTS: Treatment of the buttocks with PLLA-SCA resulted in significant reduction of depression depth, improvement in the morphological appearance of the skin, improvement in the grade of skin laxity, and overall improvement in cellulite appearance. Treated thighs showed reduction in the depth and number of depressions and an improvement in overall cellulite appearance. No significant procedure side effects were found. CONCLUSION: Poly- l lactic acid offers an effective and safe method for treating cellulite of the buttocks and thighs.


Assuntos
Celulite , Técnicas Cosméticas , Humanos , Feminino , Celulite/tratamento farmacológico , Celulite/cirurgia , Coxa da Perna , Nádegas , Estudos Prospectivos , Ácido Láctico/efeitos adversos
19.
Aesthet Surg J ; 43(1): 97-108, 2023 01 09.
Artigo em Inglês | MEDLINE | ID: mdl-35788634

RESUMO

BACKGROUND: Cellulite is an aesthetic condition affecting the appearance of skin in certain body regions and is associated with body dissatisfaction, psychosocial stress, and decreased quality of life. Previous studies established the safety and feasibility of a novel, minimally invasive device to identify and release septa responsible for cellulite depressions: targeted verifiable subcision (TVS). OBJECTIVES: The objective of this single-arm, open-label, multicenter study was to evaluate the safety and efficacy of TVS for reducing the appearance of moderate to severe cellulite in adult women. METHODS: Adult women aged 21 to 55 years and a BMI < 30 kg/m2 with moderate or severe cellulite on the buttocks and/or thighs were eligible to enroll at 9 sites. Endpoint data included results from 4 of the postprocedural follow-up visits at 24 hours, 7 days, 30 days, and 90 days. The primary endpoints were a mean ≥1 point reduction in the Cellulite Severity Scale at 90 days and no related serious adverse events at 30 days. RESULTS: Seventy-four female participants with a mean BMI of 24.8 ±â€…2.7 and age of 41.4 ±â€…7.4 years received this single procedure. The mean improvement in Cellulite Severity Scale (N = 68) was 1.5 ±â€…0.9 (P < 0.0001). There were no device-related serious adverse events at 30 days. CONCLUSIONS: TVS for selectively identifying and verifiably releasing septa responsible for cellulite depressions is an effective and safe means to improve the appearance of moderate to severe cellulite in adult women.


Assuntos
Celulite , Satisfação do Paciente , Adulto , Feminino , Humanos , Resultado do Tratamento , Celulite/cirurgia , Qualidade de Vida , Nádegas/cirurgia , Coxa da Perna
20.
Aesthet Surg J ; 43(4): 455-466, 2023 03 15.
Artigo em Inglês | MEDLINE | ID: mdl-36351188

RESUMO

BACKGROUND: Safety and efficacy endpoints for the single-arm, multicenter, open-label pivotal study, CONtrolled Focal Fibrous Band Release Method (CONFFIRM) [NCT04743635] assessing targeted verifiable subcision (TVS) for the treatment of cellulite were met at 3 months postprocedure and have been published. Final, 12-month data describing durability of treatment effect and safety are presented here for the first time. OBJECTIVES: The authors sought to evaluate safety and efficacy out to 12 months of initial treatment for a single TVS procedure performed employing the Avéli device (Revelle Aesthetics, Inc.; Mountain View, CA) to treat cellulite on the buttock and thigh areas of adult females. METHODS: Effectiveness was determined by 3 independent physicians employing the Cellulite Severity Scale and Global Aesthetic Improvement Scale to assess improvement of baseline photographs when compared with 3-, 6- and 12-month posttreatment photographs. Blinded participant-reported outcomes and safety evaluations were also performed at all postprocedure time points. RESULTS: Clinically significant improvement in primary endpoint Cellulite Severity Scale scores were sustained out to 1 year, improving by 1.50 (P < .0001) at 3 months, 1.54 points at 6 months, and 1.48 points at 12 months. Adverse events were mild and mostly resolved by the 12-month visit. CONCLUSIONS: A single TVS treatment has durable efficacy and safety in reducing cellulite on the buttocks and thighs of women with moderate to severe cellulite out to 12 months posttreatment.


Assuntos
Celulite , Técnicas Cosméticas , Adulto , Humanos , Feminino , Satisfação do Paciente , Técnicas Cosméticas/efeitos adversos , Celulite/cirurgia , Coxa da Perna , Nádegas/cirurgia
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