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Идёт набор NCT03356132

An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants

— Наблюдательное Breast Implant; Complications Quality of Life Satisfaction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Silimed® Textured Silicone Gel-Filled Breast Implant, Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant.
Кому может быть актуально
Состояния в реестре: Breast Implant; Complications, Quality of Life, Satisfaction. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
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Официальное название

Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Textured Surface and Polyurethane Foam-coated Surface

Обзор

The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary or secondary breast augmentation using Silimed® breast implants will be followed-up through 10 years. The safety of each type of Silimed® breast implant is going to be assessed by estimating the known and unexpected short- and long-term risk / adverse event rates. The performance of each type of Silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.

Вмешательства

  • Устройство Silimed® Textured Silicone Gel-Filled Breast Implant
    Women undergoing primary and secondary breast augmentation using Silimed® Textured Silicone Gel-Filled Breast Implant.
  • Устройство Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
    Women undergoing primary and secondary breast augmentation using Silimed® silicone gel-filled breast implants with polyurethane foam covered surface.

Первичные конечные точки

  • Expected Adverse Events [Срок оценки: Every three years through the 10 years length of the study.]
  • Unexpected Adverse Events [Срок оценки: Every three years through the 10 years length of the study.]
Вторичные конечные точки (4)
  • Patient's Satisfaction in Relation to Aesthetic Result [Срок оценки: Every three years through the 10 years length of the study.]
  • Patient's Satisfaction in General [Срок оценки: Every three years through the 10 years length of the study.]
  • Evaluator's Satisfaction in Relation to Aesthetic Result [Срок оценки: Every three years through the 10 years length of the study.]
  • Patient's Quality of Life [Срок оценки: Every three years through the 10 years length of the study.]

Критерии участия

Критерии включения

  • provide written informed consent.
  • female at birth
  • be 18 years of age or older
  • have received breast implant(s) for indication of primary or secondary augmentation until 21 days before (including the visit window)
  • having received a breast implant with a textured surface or a breast implant with a surface coated with Silimed® polyurethane foam
  • ability to comply with the protocol throughout the follow-up period.

Критерии исключения

  • mammary reconstruction in at least one breast or augmentation after previous reconstruction,
  • pregnancy informed or breastfeeding at the inclusion moment,
  • advanced fibrocystic disease at the time of implantation,
  • neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation,
  • reporting or recording of adverse reactions or intolerance to polyurethane or silicone prior to implantation,
  • immune diseases affecting active connective tissue or (eg, lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation,
  • signs of inflammation of the breast or implant site at the time of implantation,
  • Increased risk of immediate postoperative complications due to use of illicit drugs or medications,
  • Increased risk of immediate post-surgical complications caused by illicit drug use or medication use,
  • have participated in another clinical study up to 6 months prior to the placement of the implant,
  • any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, renders participation in the study is unsafe, compromises adherence to the protocol, complicates the interpretation of data from the study outcome, or otherwise interferes with the achievement of study objectives.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бразилия · 1 центр
  • Perfektua Serviços Médicos Ltda — Niterói

Идентификаторы

NCT: NCT03356132 · 6002030

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗