Effectiveness of Silver Nitrate Cauterization vs Conservative Management in Tympanic Membrane Perforation Closure

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMuhammad Ali Javed

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 50% Silver Nitrate Cauterization

    Drug

    Under 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

56 Participants
are divided into 2 treatment groups
Group A: Group A - Silver Nitrate CauterizationExperimental treatment 1 intervention
Group B: Group B - Spontaneous HealingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Tympanic Membrane Perforation Closure Rate

Proportion of participants achieving complete closure (healing) of the tympanic membrane without any residual defect, confirmed by otoscopic examination.

Time frame
4 weeks post-treatment initiation

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Muhammad Ali Javed

Lead sponsor

Rawalpindi Medical College

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: