Comparison of Myringoplasty Using Porcine Small Intestinal Submucosa (Biodesign) Versus Autologous Grafts (Perichondrium, Temporalis Fascia, Cartilage, or Fat) for Tympanic Membrane Perforation Closure: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tympanic membrane perforation status (closed vs not closed)
研究概览
简要总结
The goal of this observational, retrospective study is to learn whether a ready-made graft patch (Biodesign, made from porcine small intestinal submucosa) works as well as a participant's own tissue graft (such as tragal perichondrium or temporalis fascia) to close a hole in the eardrum (tympanic membrane perforation). The main questions this study aims to answer are:
Does the eardrum hole close after surgery, and is the closure rate similar between Biodesign and autologous tissue grafts?
Do participants have similar hearing improvement after surgery (measured by the air-bone gap, a common hearing test measure)?
Is the operating time different between the graft types?
Are there differences in complications or adverse reactions?
Study hypothesis: Biodesign will have a similar eardrum closure rate compared with autologous tissue grafts, with similar hearing improvement and low complication rates, and may be associated with a shorter operating time.
How the study will work: Investigators will review medical records of participants who had myringoplasty/tympanoplasty for eardrum perforation in the department between 2020 and 2024. Data already recorded as part of usual care will be collected, including: pre-surgery eardrum findings (size and location of the perforation) and hearing tests; operative details (technique and operating time); and follow-up at about 3 months, including an ear exam to confirm closure and check for adverse reactions, plus a hearing test. Participants will be excluded if they have other ear conditions (such as cholesteatoma, otosclerosis, or tympanosclerosis), if the eardrum was described as flaccid, or if follow-up or post-operative hearing data are missing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with tympanic membrane perforation and undergoing myringoplasty by our department between 2020 and 2024
排除标准
- •Patients with cholesteatoma, otosclerosis, tympanosclerosis.
- •Operations that describe a flaccid tympanic membrane and those that included more than one graft material.
- •No follow up data or no post-operative audiometry.
研究组 & 干预措施
Biodesign
Participants with tympanic membrane perforation who underwent myringoplasty/tympanoplasty using a porcine small intestinal submucosa (Biodesign) graft for perforation repair.
干预措施: tympanoplasty using Biodesign (Procedure)
Autologous grafts
Participants with tympanic membrane perforation who underwent myringoplasty/tympanoplasty using the participant's own tissue for perforation repair (tragal perichondrium, temporalis fascia, cartilage, or fat), as documented in the operative report.
干预措施: tympanoplasty using autologous tissue graft (Procedure)
结局指标
主要结局
Tympanic membrane perforation status (closed vs not closed)
时间窗: Three months after surgery
Tympanic membrane status will be determined from postoperative ear examination (otoscopy or microscopy) documented in the medical record. The measure is the proportion of participants with an intact tympanic membrane (no residual perforation) at the follow-up visit closest to 3 months after surgery.
次要结局
- Change in air-bone gap (operated ear)(Three months after surgery)
