Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Assessment of graft take after tympanoplasty
研究概览
简要总结
This is a prospective, randomized trial to evaluate tympanoplasty outcomes using Biodesign SIS graft compared to autologous temporalis fascia, the most commonly used graft for repair of tympanic membrane.
详细描述
Patients 18 years or older will undergo primary tympanoplasty without mastoidectomy. The patients will be randomized into groups receiving Biodesign versus autograft temporalis fascia for repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients undergoing primary tympanoplasty without mastoidectomy.
排除标准
- •Patients with a known biologic sensitivity or a cultural objection to use of porcine materials.
研究组 & 干预措施
Biodesign graft tympanic membrane repair
Patient's perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft
干预措施: Biodesign Otologic graft (Biological)
Autograft tympanic membrane repair
Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia.
干预措施: Autologous temporalis fascia (Other)
结局指标
主要结局
Assessment of graft take after tympanoplasty
时间窗: 6 months postoperatively by the surgeon
Microscopically evaluate tympanic membrane for perforation closure
次要结局
- Measurement of Hearing Parameters(Measure hearing parameters 6 months postoperatively)