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Идёт набор NCT05190978

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Без фазы С лечением Breast Cancer 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
В протоколе указаны: Acellular Dermal Matrix, Reconstruction without ADM.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Breast Implant; Complications, Infection or Inflammation. Базовые параметры: 22 лет — 75 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
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Обзор

Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.

Подробное описание

One in eight women will develop breast cancer in her lifetime, causing both physical and psychological trauma due to invasive treatments and the distress associated with removal of a breast. Breast reconstruction after mastectomy has become a critical procedure for many women to restore psychological wellbeing, with implant-based reconstruction the most common approach. Nearly 100,000 patients undergo reconstruction with implants every year in the United States.

Surgical mesh devices, particularly acellular dermal matrices, are now used off-label by most reconstructive surgeons performing prosthetic breast reconstruction. In the past decade, surgeons have advocated a transition from submuscular reconstruction (placement of the implant under the pectoralis muscle) to pre-pectoral (placement above the pectoralis) and often consider mesh to be necessary for this procedure. Surgical mesh has not been approved by the FDA for breast reconstruction for either anatomic location. These mesh devices are considered Class III medical devices and FDA recently prioritized the evaluation of these products during a panel meeting in 2019.

No Level I randomized trial has been successfully performed to determine the actual risks and benefits of mesh devices in breast reconstruction. This study proposes a pilot study as the first ever randomized, multi-center trial for mesh assistance in two-stage prosthetic pre-pectoral breast reconstruction, across the major manufacturers. The goals are to demonstrate feasibility of such a study and to generate high level data toward the evaluation of safety and effectiveness of these products for the benefit of women's public health

Вмешательства

  • Устройство Acellular Dermal Matrix
    Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort.
  • Процедура Reconstruction without ADM
    Acellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort.

Первичные конечные точки

  • Safety - Major Complications [Срок оценки: 2 years]
  • Effectiveness - BREASTQ [Срок оценки: 2 years]
Вторичные конечные точки (3)
  • Secondary Effectiveness [Срок оценки: 2 years]
  • Secondary Safety [Срок оценки: 2 years]
  • Capsular Contracture [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders
  • Prophylactic and oncologic mastectomies are both acceptable
  • Nipple sparing and skin sparing mastectomy techniques are both acceptable

Критерии исключения

  • Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast
  • Bilateral reconstruction patients undergoing contralateral submuscular reconstruction
  • Direct-to-implant reconstruction
  • Pregnancy
  • Delayed reconstruction

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of California Los Angeles — Los Angeles

Идентификаторы

NCT: NCT05190978 · 190311

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗