NCT07833670

Brief Summary

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

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jan 2027

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 16, 2026

Last Update Submit

September 16, 2026

Conditions

Tympanic Membrane Perforation

Keywords

silver nitrateChemical cauterizationTympanic Membrane PerforationSpontaneous HealingGel foam Patching

Outcome Measures

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.

    4 weeks post-treatment initiation

Study Arms (2)

Group A - Silver Nitrate Cauterization

EXPERIMENTAL

Microscopic application of 50% silver nitrate stick to the margins of the tympanic membrane perforation until blanching occurs, followed by Gel foam placement. Repeated weekly for up to 4 weeks

Drug: 50% Silver Nitrate Cauterization

Group B - Spontaneous Healing

NO INTERVENTION

Conservative management without active chemical or surgical intervention, observing for spontaneous healing over a 4-week period.

Interventions

50% Silver Nitrate CauterizationDRUG

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.

Also known as: Chemical Cautery with Gel foam Patching
Group A - Silver Nitrate Cauterization

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tympanic Membrane PerforationRemission, Spontaneous

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesWounds and InjuriesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Muhammad Ali Javed, MBBS

CONTACT

03295718202drali.javed911@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned to either Group A (50% silver nitrate cauterization) or Group B (conservative management/spontaneous healing) and followed weekly for 4 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 22, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share