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NCT Number: NCT07833670

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Chemical Cautery with Gel foam Patching

Primary outcomes

  1. Tympanic Membrane Perforation Closure Rate

    Time frame: 4 weeks post-treatment initiation

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

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Ali Javed, MBBS

CONTACT

[email protected]

03295718202

Sponsors and collaborators

Lead sponsor

Muhammad Ali Javed

Other

Registry information

Official study title

Effectiveness of Silver Nitrate Cauterization in the Closure of Tympanic Membrane Perforation

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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