Fibrinogen- Based Collagen Fleece Graft Myringoplasty for Chronic Tympanic Membrane Perforations - a Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 27
- 主要终点
- closure of tympanic membrane perforation
研究概览
简要总结
Tympanic membrane perforations are common medical problem that encounters a lot of patients in all age groups.
The gold standard for treatment of perforations is tympanic membrane closure procedure (tympanoplasty) which is done under general anesthesia.
This procedure could be problematic for many patients who are not suitable for general anesthesia due to their medical status.
It's also time consuming for the patient and for the medical system, since it takes a lot of time to reach the operation room and hospitalization for at least two days.
The purpose in this study is to use Tachosil (Fibrinogen based patch) under local anesthesia to close tympanic membrane perforations.
Tachosil is in use for hemostasis and for tissue repair after injury. Tachosil is bound to the tissue and form a waterproof membrane. In the setting of ENT clinic and under local anesthesia, the investigators will start the procedure with debridement of the tympanic perforation edges, then they will close the perforation using two pieces of Tachosil under and above the perforation in the right form (active side to the active side).
If the results will be similar to tympanoplasty results, this method may be used for closure of tympanic perforation and save time and money for the patient and for the health system.
详细描述
Tympanoplasty is the gold standard treatment for tympanic membrane perforation.
It is done under general anesthesia in the following form:
Incision in the post auricular area, harvesting of fascia and cartilage from the concha of the pinna .
In Trans ear canal approach starting with debridement of the edges of the tympanic membrane perforation and closing the perforation using cartilage and fascia.
After being informed about the study and potential risks, all patients giving informed consent will participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic tympanic membrane perforation
- •dry ear at least 4 weeks before the procedure
- •no evidence of cholesteatoma
- •hearing test in the last 3 months
- •signing informed consent
排除标准
- •age under 18 years
- •breastfeeding
- •a known sensitivity for any ingredient
- •a perforation that is more than one third of the tympanic membrane area.
- •new onset perforation (less than 3 months)
结局指标
主要结局
closure of tympanic membrane perforation
时间窗: one month after the procedure
one month post operative the patient will be re-examined in the clinic to see if the perforation is closed.
次要结局
未报告次要终点