Effectiveness of Silver Nitrate Cauterization in the Closure of Tympanic Membrane Perforation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 主要终点
- Tympanic Membrane Perforation Closure Rate
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of 50% silver nitrate chemical cauterization compared to conservative management (spontaneous healing) in closing small, dry tympanic membrane perforations. Patients presenting with a small (<4 mm), dry, unilateral tympanic membrane perforation will be assigned to either receive weekly applications of 50% silver nitrate for up to 4 weeks or undergo observation for spontaneous healing. The primary outcome is to assess and compare the proportion of patients achieving complete tympanic membrane closure after 4 weeks of follow-up
详细描述
Tympanic membrane perforation is a common clinical condition resulting primarily from middle ear infections or trauma. While small perforations can heal spontaneously, active intervention may be required to accelerate healing and prevent chronic complications. In this quasi-experimental comparative study conducted at the Department of Otorhinolaryngology, Rawalpindi Teaching Hospital, eligible participants aged 18 to 60 years with small, dry, unilateral pars tensa perforations are allocated into two groups based on clinical observation and patient preference: Intervention Group (Group A): Participants undergo microscopic cauterization using 50% silver nitrate applied to the perforation margins until blanching occurs, followed by Gel foam placement. This procedure is repeated weekly for up to 4 weeks. Control Group (Group B): Participants are managed conservatively to observe spontaneous healing without chemical intervention over 4 weeks. All participants are evaluated weekly for 4 weeks via otoscopic examination to monitor healing progress. Statistical analysis will compare total healing rates between groups and stratify for confounding variables such as age, gender, etiology, and initial perforation size.
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 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 60 years
- •Small, unilateral tympanic membrane perforation in the pars tensa (<25% of surface area, present in one quadrant)
- •Dry perforation for at least 4 weeks
- •Perforation size <4 mm in diameter
- •Conductive hearing loss with an air-bone gap of ≥15 dB on Pure Tone Audiometry (PTA)
排除标准
- •Age <18 years or >60 years
- •Bilateral tympanic membrane perforations
- •Perforation size >4 mm in diameter
- •Discharging ear
- •Edematous middle ear mucosa
- •Presence of cholesteatoma, granulations, or retraction pockets
- •Presence of sensorineural or mixed hearing loss on PTA
- •Patients with diabetes mellitus
- •Known allergy to silver nitrate
- •Unwillingness to undergo silver nitrate cautery or adhere to weekly follow-up
研究组 & 干预措施
Group A - Silver Nitrate Cauterization
Microscopic application of 50% silver nitrate stick to the margins of the tympanic membrane perforation until blanching occurs, followed by Gel foam placement. Repeated weekly for up to 4 weeks
干预措施: 50% Silver Nitrate Cauterization (Drug)
Group B - Spontaneous Healing
Conservative management without active chemical or surgical intervention, observing for spontaneous healing over a 4-week period.
结局指标
主要结局
Tympanic Membrane Perforation Closure Rate
时间窗: 4 weeks post-treatment initiation
Proportion of participants achieving complete closure (healing) of the tympanic membrane without any residual defect, confirmed by otoscopic examination.
次要结局
未报告次要终点
研究者
Muhammad Ali Javed
Clinical Professor
Rawalpindi Medical College
