A Prospective Comparative Study of Dry vs Wet Temporalis Fascia Graft in Tympanoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
研究概览
简要总结
This study was conducted to compare two methods of using temporalis fascia graft in tympanoplasty, namely wet temporalis fascia graft and dry temporalis fascia graft. Tympanoplasty is an ear surgery performed to repair a hole in the ear drum and to improve hearing in patients with chronic otitis media. Temporalis fascia is a thin layer of tissue taken from the area over the temple muscle and is commonly used as graft material for repair of the ear drum.
The study included adult patients aged 18 to 60 years who had chronic otitis media with inactive mucosal disease, a large central perforation of the ear drum, and conductive hearing loss confirmed on pure-tone audiometry. Patients were assigned to one of two treatment groups. One group underwent tympanoplasty using a wet temporalis fascia graft, while the other group underwent tympanoplasty using a dry temporalis fascia graft.
The main purpose of the study was to assess whether one graft preparation technique gave better surgical and hearing outcomes than the other. The outcomes were assessed three months after surgery. Hearing improvement was measured by comparing the air-bone gap before and after surgery on pure-tone audiometry. Graft success was assessed by otoscopic examination to determine whether the graft had healed properly, remained in correct position, and closed the ear drum perforation. Complete air-bone gap closure was also assessed as an additional hearing outcome.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 60 years.
- •Patients of either gender.
- •Patients diagnosed with chronic otitis media.
- •Patients with inactive mucosal disease, with no active ear discharge.
- •Patients with a large central perforation of the tympanic membrane.
- •Tympanic membrane perforation persisting for at least 6 weeks.
- •Patients with pure conductive hearing loss confirmed on pure-tone audiometry.
排除标准
- •Patients with active otitis media, acute infection, or active ear discharge.
- •Patients with tympanosclerosis or ossicular necrosis affecting ossicular chain mobility.
- •Patients with a history of previous ear surgery that could affect tympanoplasty outcomes, such as ossiculoplasty or mastoidectomy, except prior myringotomy.
- •Patients with sensorineural hearing loss or mixed hearing loss.
- •Patients with conditions impairing wound healing or postoperative care compliance, including uncontrolled diabetes mellitus or immunodeficiency disorders.
- •Patients with confirmed Eustachian tube dysfunction.
- •Patients with active infection in the throat, nose, paranasal sinuses, or oral cavity.
- •Patients with bleeding disorders.
研究者
Muhammad Israr
Principal Investigator
Shaikh Zayed Hospital, Lahore