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临床试验/NCT06339294
NCT06339294已完成1 期

Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Treatment of Otomycosis: a Randomized Controlled Clinical Trial

Rawalpindi Medical College1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年6月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Treatment Response Based on Otoscopy

研究概览

简要总结

Background and Objectives To compare the efficacy of gel foam-soaked pyodine with a single topical application of clotrimazole ointment.

Subjects and Methods This randomized controlled trial will include 90 patients presenting to ENT OPD with complaints of earache, watery ear discharge, pruritis, and ear blockage and will be clinically diagnosed as a case of otomycosis on otoscopy. The external auditory canal of the patient will be cleared of fungal debris via suction before treatment In Group A ear canal will be filled with 1% clotrimazole ointment by using an IV catheter and syringe and in Group B pyodine-soaked gel foam will be placed in the external auditory canal. The patients will be followed up on post-treatment days 7 and 14.

详细描述

INTRODUCTION:

Otomycosis, external auditory canal fungal infection is a recurrent and prevalent condition affecting 9%to 27.2% of patients worldwide. Use of topical antibiotics, humid conditions, and trauma to the external auditory canal are well-recognized risk factors for this disease. Aspergillus nigar (60-90%), and Candida species (10-40%) are the most commonly isolated pathogens in patients with otomycosis. Otomycosis presents with bothersome symptoms such as pruritis, watery ear discharge, otalgia, and ear blockage which significantly impairs the patient's quality of life Therapeutic approaches for fungal ear infections include aural toilet, withholding topical antibiotics, starting topical antifungals, and enhancing patient well-being and cleanliness Multiple treatment options are available for the treatment of otomycosis but the recurrence rate of the disease is high. While several antifungal agents have been employed for its treatment, due to a lack of efficacy comparison it is difficult to select an appropriate option The choice of therapy plays an important role in achieving rapid symptom resolution and complete fungal eradication. Clotrimazole, a conventional antifungal agent, has been widely employed, but its efficacy is not always optimal. For topical treatment compliance of the patient and proper application of medication is also an important factor affecting the efficacy of the drug. Conversely, the utilization of pyodine-soaked Gelfoam is a novel approach that offers several advantages, including sustained drug release better drug penetration, and decreased risk of resistance as in the case of antifungals.

Due to reduced compliance of the patients and ineffective technique of using topical antifungal otomycosis has a high rate of treatment failure and recurrence. Topical clotrimazole drops and povidine iodine solution have been compared for their efficacy in the past but a single topical application has not been compared until now. In this pursuit, we present a rigorous and comprehensive clinical trial designed to evaluate the comparative efficacy of two distinct treatment modalities: pyodine-soaked Gelfoam and a single topical application of 1% clotrimazole. The rationale behind this study is to address the escalating concerns regarding treatment-resistant otomycosis, as well as the need for cost-effective and practical solutions By addressing the question of which treatment is superior, this study endeavors to optimize the management of otomycosis, ensuring better patient outcomes and reduced healthcare costs.

MATERIAL & METHODS:

The main objective of this study is to evaluate the effectiveness of povidone iodine-soaked gel foam vs clotrimazole ointment in the management of otomycosis. A randomized controlled study was done in the ENT Department of Benazir Bhutto Hospital Rawalpindi over a period of 6 months from June 2023 to December 2023.

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
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients with clinical diagnosis of otomycosis via otoscopy

排除标准

  • Active CSOM
  • External auditory canal abnormalities
  • Patients on hearing aids

研究组 & 干预措施

Group A (clotrimazole ointment group)

Experimental

Clotrimzole ointment

1ml dose Frequency one time application Duration one time application with aural toilet after 7 days

干预措施: Clotrimazole Cream (Drug)

Group B(Povidone Iodine group)

Experimental

Povidone iodine solution

1ml dose Frequency one time application Duration one time application with aural toilet after 7 days

干预措施: Povidone-Iodine (Drug)

结局指标

主要结局

Treatment Response Based on Otoscopy

时间窗: 7th and 14th post treatment day

Good response Patients with a dry EAC and tympanic membrane intact with no fungal spores Partial Response: Patients with scanty discharge but not completely dry EAC with no fungal spores No Response: Patients with unusually high EAC Exudation with fungal spores present

次要结局

  • Condition of External Auditory Canal(7th and 14th post treatment day)

研究者

发起方
Rawalpindi Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Zuneera Shabbir

Primary Investigator

Rawalpindi Medical College

研究点 (1)

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