Effectiveness of Acetic Acid Ear Drops Versus Standard Treatment in Medical Management of Chronic Suppurative Otitis Media
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Dry ear status after 30 days.
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness of 2% acetic acid ear drops with 0.3% ciprofloxacin ear drops in the medical management of chronic suppurative otitis media (CSOM). The study will be conducted among adults aged 18 to 70 years attending the Otorhinolaryngology Department of Dr. Ruth K.M. Pfau Civil Hospital, Karachi. Participants will be randomly allocated to receive either 2% acetic acid or 0.3% ciprofloxacin ear drops three times daily for one month. Treatment effectiveness will be assessed by achievement of a dry ear and improvement in otological symptom score.
详细描述
Background and rationale:
Chronic Suppurative Otitis Media (CSOM) is a chronic inflammatory condition of the middle ear and mastoid cavity characterized by persistent or recurrent ear discharge through a perforated tympanic membrane. It is more common in developing countries and can lead to complications including tympanosclerosis, cholesteatoma, and ossicular necrosis if inadequately treated.
Current treatment:
Tubotympanic CSOM is primarily managed conservatively with aural toilet and topical antimicrobial therapy. Topical ciprofloxacin is commonly used because of its effectiveness against CSOM pathogens and favorable safety profile. However, increasing antibiotic resistance has encouraged the evaluation of alternative topical treatment options.
Rationale for acetic acid:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Persistent, non-foul-smelling ear discharge for ≥3 months
- •Tubotympanic type chronic suppurative otitis media
- •Baseline otological symptom score ≥5
排除标准
- •Immunocompromised patients
- •External auditory canal pathology
- •Ear malignancy
- •Known hypersensitivity to acetic acid or ciprofloxacin
- •Pregnant women or lactating mothers
研究组 & 干预措施
2% Acetic Acid Ear Drops
Participants will receive 2% acetic acid ear drops, 3 drops in the affected ear three times daily for one month.
干预措施: Acetic Acid 2% Ear Drops (Drug)
0.3% Ciprofloxacin Ear Drops
Participants will receive 0.3% ciprofloxacin ear drops, 3 drops in the affected ear three times daily for one month.
干预措施: Ciprofloxacin 0.3% Otic Solution (Drug)
结局指标
主要结局
Dry ear status after 30 days.
时间窗: 30 days after intial treatment
Proportion of participant with a dry ear: defined as absence of moisture or ear discharge on clinical examination with an otological symptom score of ≤2 after 30 days of initial treatment.
次要结局
- Ear discharge status(7, 14 and 30 days after the initiation of treatment)
- Otological symptom score(7, 14 and 30 days after the initiation of treatment)
- Treatment adherence and tolerability(30 days after initiation of treatment.)
- ear discharge status at followup.(30 days after completion of treatment)
- 5. Adverse effects associated with treatment(30 days after initiation of treatment)
研究者
Dr. Asra Waseem
Principal Investigator
Dow University of Health Sciences