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Идёт набор NCT05736354

Molecular Mechanisms Associated With Breast Implant Complications

— Наблюдательное Breast Implant; Complications Infection or Inflammation

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Breast Implant; Complications, Infection or Inflammation. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of Breast Implant Illness. Three patient cohorts will be studied (A) Subjects with breast implant with BII manifestations (B) Subjects with breast implants without BII manifestations (C) Subjects without breast implants who underwent breast surgery procedure. Blood, surgically discarded tissue, implants, and associated capsules will be collected through this protocol.

Подробное описание

Breast implants were first introduced in 1962. It is estimated that 10 million women worldwide, including three million Americans have breast implants. There has been increased identification of patients experiencing a constellation of symptoms related to their implants. For breast implants, these symptoms are often associated with autoimmune and connective tissue disorders (CTD) and have been referred to as Breast Implant Illness (BII). A growing number of patients 30,000 annually are seeking to have their breast implants removed. In view of the implant associated complications, the US Food and Drug Administration (FDA) has placed a black box warning on breast implants. Limited research has resulted in a void in the prognosis of this surgical problem. Bacterial biofilms are becoming a major concern for medical device implants. Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of BII.

This research studies oxilidized lipids (oxylipins). These are metabolities formed as a result of host-biofilm interaction. The presence of oxylipins will be studied in peri-prosthetic tissue post-biofilm infection and in systemic circulation. Oxylipins are immunogenic. Hence, the investigators will also study the abundance of immune cells T cells and macrophages (types and subtypes) and associated cytokines.

Первичные конечные точки

  • Presence of Biofilm in Breast Tissue [Срок оценки: Through study completion, an average of 1 year]
  • Analysis of host-biofilm interaction mediated oxylipins from blood [Срок оценки: Through study completion, an average of 1 year]
  • Cytokine analysis will be performed on breast tissue [Срок оценки: Through study completion, an average of 1 year]
  • Analysis of host-biofilm interaction mediated oxylipins from breast tissue [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (1)
  • CD4+ Immunological Activation due to Host Implant Interaction [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Inclusion Criteria for breast implant subjects:

  • Age greater than or equal to 18 years
  • Undergoing removal of breast implant
  • Willing and able to comply with protocol instructions

Inclusion Criteria for subjects undergoing breast surgeries (other than implant removal)

  • Age greater than or equal to 18 years
  • Undergoing breast surgery
  • Willing and able to comply with protocol instructions

Критерии исключения

  • Individuals who are deemed unable to understand the procedures, risks, and benefits of the study, (i.e., unable to provide informed consent)
  • Pregnant females
  • Immunodeficiency (HIV/AIDS, SCID)
  • Currently on immunosuppressive medications
  • Prisoners

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 3 центра
  • IU Health North Hospital — Carmel
  • Meridian Plastic Surgeons — Carmel
  • IU Health Methodist Hospital — Indianapolis

Идентификаторы

NCT: NCT05736354 · 2003674175 · R21AI171932 · R01AI165958

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗