About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age <18 years or >60 years
Bilateral tympanic membrane perforations
Perforation size >4 mm in diameter
Discharging ear
Trial design
Parallel
Treatments tested in this trial
50% Silver Nitrate Cauterization
DrugUnder microscopic visualization, 50% silver nitrate is applied to the margins of the tympanic membrane perforation until blanching occurs, followed by Gel foam placement. The procedure is repeated weekly for up to 4 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Tympanic Membrane Perforation Closure Rate
Proportion of participants achieving complete closure (healing) of the tympanic membrane without any residual defect, confirmed by otoscopic examination.
Locations
Sponsors and contacts
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Muhammad Ali Javed
Lead sponsor
Rawalpindi Medical College
Sponsor institution
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