Clinical Outcomes of Bioactive Glass S53P4 in Radical Mastoid Cavity Obliteration
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: Mastoid cavity obliteration with S53P4 bioactive glass.
- Кому может быть актуально
- Состояния в реестре: Tympanoplasty. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Impact of Quality of Life After Radical Cavity Revision and Obliteration With S53P4 Bioactive Glass Granules
Обзор
Radical cavities resulting from open tympanoplasty performed for chronic cholesteatomatous otitis may lead to postoperative complications and negatively affect patients' quality of life. These cavities can remain unstable and may be associated with persistent otorrhea, limitations in the use of hearing aids, and the need to avoid water exposure, all of which may significantly impact daily activities. Although mastoid and paratympanic cavity obliteration techniques are increasingly used during primary surgery, many patients previously treated with open tympanoplasty continue to present with problematic postoperative cavities. Obliteration procedures have been proposed in revision surgery to improve cavity stability and reduce complications. Bioactive glass S53P4 has recently attracted interest as an obliterative material due to its long-term stability, biocompatibility, antibacterial properties, and ability to integrate with surrounding tissues. However, evidence regarding the medium-term clinical outcomes of this approach remains limited. The aim of this study is to evaluate the clinical effectiveness and safety of mastoid cavity obliteration using bioactive glass S53P4 in patients with radical cavities following open tympanoplasty. The study will assess surgical success, complication rates, and the impact of the procedure on patient quality of life.
Вмешательства
- Процедура Mastoid cavity obliteration with S53P4 bioactive glass
Surgical obliteration of symptomatic radical mastoid cavities using S53P4 bioactive glass as obliterative material during revision surgery after previous open tympanoplasty.
Первичные конечные точки
- Quality of Life Improvement After Mastoid Cavity Obliteration With S53P4 [Срок оценки: 3 months after surgery]
Вторичные конечные точки (5)
- Change in quality of life (GBI score) [Срок оценки: 3 months after surgery]
- Change in audiometric hearing thresholds [Срок оценки: 3 months after surgery]
- Resolution of otorrhea [Срок оценки: 3 months after surgery]
- External auditory canal condition [Срок оценки: 3 months after surgery]
- Change in cavity volume [Срок оценки: 3 months after surgery]
Критерии участия
Критерии включения
- underwent a canal wall down tympanoplasty or a previous obliteration attempt more than a year ago
- present with symptoms related to unstable cavity such as discharge, vertigo, impaired water activities or difficulty with hearing aids will be included
- patients Over 18 years who signed informed consent
Критерии исключения
- Active cholesteatoma
- Earlier radiation of Head and Neck area
- Pregnancy
- Important systemic comorbidities
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- Trial Office — Legnano
Идентификаторы
NCT: NCT07496112 · 16-2025