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Набор скоро начнётся NCT06505252

Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty: a Randomized Clinical Study

Без фазы С лечением Chronic Suppurative Otitis Media

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: enoscopic Myringoplasty.
Кому может быть актуально
Состояния в реестре: Chronic Suppurative Otitis Media. Базовые параметры: 14 лет — 50 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
Список центров уточняется — проверьте первичный протокол.
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

Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty

Обзор

This study aimed to compare the effect of adding HA versus PRP to endoscopic FGM in cases of small or medium-sized central TM perforation in the form of: 1. Evaluation of the graft uptake rate. 2. Evaluation and comparing audiological outcomes. 3. Finding out intraoperative and postoperative morbidity.

Подробное описание

Tympanic membrane (TM) perforations result in recurrent middle ear infection and hearing loss. Both these hazards can be prevented by the reconstructive surgery of the tympanic membrane.

Fat graft myringoplasty (FGM) has been reported as a suitable procedure to close long-standing TM perforations FGM is an efficient, safe and potentially fast method for TM perforation repairing with a success rate varies from 79% to 91%..Many researches was done to use supporting material in myringoplasty Saliba et al used hyaluronic acid fat graft myringoplasty \[HAFGM\] and results in a higher success rate than using FGM alone. El-Anwar et al proved that Topical autologous platelet-rich plasma(PRP) application during myringolpasty is safe, efficient and enhances healing of TM perforation PRP includes many autologous growth factors that have significant functions like cell proliferation, migration, and angiogenesis. Fibrin and fibronectin are essential proteins in PRP that provide the structural support needed for the cell migration, cell proliferation, and 3-dimensional growth of tissues.

HA has been shown to play a role in cellular signaling, leukocyte growth and migration, Cell adhesion and biological remodeling and is mainly involved in tissue healing with a central role in modulating inflammatory responses also, Its absorption of water causes expansion in volume and formation of a viscoelastic gel which constitutes a favorable scaffold for tissue regeneration and remodeling .

Вмешательства

  • Процедура enoscopic Myringoplasty
    general anesthesia. A single surgeon will perform all surgeries. * A small incision in the rim of ear lobule on the same side of the operated ear, a small piece of adipose tissue will be removed according to the experience of the surgeon. * Using 0 angulation endoscope visualization, the edges of the perforation will be refreshed and deepithelialized with a sharp Rosen's needle * sponge gel (Gelfoam) will pushed through TM perforation into the middle ear to support the graft and to avoid its me

Первичные конечные точки

  • graft taking [Срок оценки: 3 months]
Вторичные конечные точки (2)
  • Audiotympanogram [Срок оценки: 3 months]
  • Otorrhea [Срок оценки: 1 month]

Критерии участия

Критерии включения

  • Patients with central small or median sized dry perforation
  • Aged between 14 and 50 years
  • In cases of CSOM the perforation must be dry with no otorrhea with healthy middle ear mucosa for at least three month without medications
  • Conductive gap on audiometry not more than 40 dB.

Критерии исключения

  • Discharging CSOM .
  • Concurrent URTI .
  • CSOM with dry marginal perforation
  • Patients who didn't come for follow up.
  • Age less than 14 or more than 50.
  • Unsafe CSOM with cholesteatoma, apparent retraction pockets, granulations, or extensive myringosclerosis reaching the edges of the perforation. Patients
  • Patients who are suspected of having Eustachian tube dysfunction.
  • Suspected ossicular pathology in safe CSOM if the ABG \> 40dB.
  • Patients with history of Previous ear surgery.
  • Patients unfit for surgery or having chronic medical illness.
  • Narrow external auditory canal.
  • Patients who refused to enrolled in our study
  • Patients with sensorineural hearing loss or only functioning ear.

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

Список центров уточняется — проверьте первичный протокол.

Публикации

  • El-Anwar MW, El-Ahl MA, Zidan AA, Yacoup MA. Topical use of autologous platelet rich plasma in myringoplasty. Auris Nasus Larynx. 2015 Oct;42(5):365-8. doi: 10.1016/j.anl.2015.02.016. Epub 2015 Mar 17. PMID 25794691
  • Knutsson J, Kahlin A, von Unge M. Clinical and audiological short-term and long-term outcomes of fat graft myringoplasty. Acta Otolaryngol. 2017 Sep;137(9):940-944. doi: 10.1080/00016489.2017.1326063. Epub 2017 May 24. PMID 28537107
  • Kim HC, Park KS, Yang HC, Jang CH. Surgical results and factors affecting outcome in patients with fat-graft myringoplasty. Ear Nose Throat J. 2024 Jul;103(7):442-446. doi: 10.1177/01455613211063243. Epub 2021 Dec 9. PMID 34881650

Идентификаторы

NCT: NCT06505252 · Endoscopic fat Myringoplasty

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗