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TerminatedNCT07833670Updated Nov 2, 2026

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

An interventional study of 50% Silver Nitrate Cauterization in Tympanic Membrane Perforation, sponsored by Muhammad Ali Javed. Terminated at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Muhammad Ali Javed · Not applicable, Interventional, and Treatment

Why this study was terminated
Don't want to continue

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Feb 2026, registered Sep 2026).
Updated Nov 2, 2026Now TerminatedFirst site in Pakistan+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

Read the detailed description

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.

02

Conditions studied

  • Tympanic Membrane Perforation

Keywords

  • silver nitrate
  • Chemical cauterization
  • Tympanic Membrane Perforation
  • Spontaneous Healing
  • Gel foam Patching
03

In context

Tympanic Membrane Perforation

53 studies on the registry are indexed under Tympanic Membrane Perforation; 14 are open to participants now.

This study's enrollment of 56 is close to the median of 57 across 39 interventional studies indexed under Tympanic Membrane Perforation.

Browse Tympanic Membrane Perforation studies →

Lead sponsor

Muhammad Ali Javed is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Group A - Silver Nitrate Cauterization

    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

  • No intervention
    Group B - Spontaneous Healing

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

Interventions

  • Drug50% Silver Nitrate Cauterization

    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

06

What researchers measure

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

07

Study locations

1 site
  • Rawalpindi Teaching Hospital
    Rawalpindi, 46000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Feb 2026 to primary completion in Jul 2026, 5 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 2, 2026: start Jan 2027 → Feb 2026, primary completion Jul 2027 → Jul 2026 and completion Aug 2027 → Aug 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2026
First posted
Sep 22, 2026
StartActual
Feb 1, 2026was Jan 2027
Primary completionActual
Jul 1, 2026was Jul 2027
CompletionActual
Aug 1, 2026was Aug 2027
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Terminated Don't want to continue
changed Nov 2, 2026
Sites
1 site added — first site in Pakistan
Show site
  • Rawalpindi Teaching Hospital · Rawalpindi, Pakistan
Nov 2, 2026
Start date
Jan 1, 2027→Feb 1, 2026 (actual)
Nov 2, 2026
Primary completion
Jul 1, 2027→Jul 1, 2026 (actual)
Nov 2, 2026
Study completion
Aug 1, 2027→Aug 1, 2026 (actual)
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Not yet recruiting→Terminated
    Why stopped Don't want to continue
    1 site added — first site in Pakistan
    Show site
    • Rawalpindi Teaching Hospital · Rawalpindi, Pakistan
    Start date Jan 1, 2027→Feb 1, 2026 (now actual)
    Primary completion Jul 1, 2027→Jul 1, 2026 (now actual)
    Study completion Aug 1, 2027→Aug 1, 2026 (now actual)
    + 1 other change: contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07833670
Lead sponsor
Muhammad Ali Javed
Responsible party
Muhammad Ali Javed (Clinical Professor, Rawalpindi Medical College) — Sponsor-investigator
First posted
Sep 22, 2026
Start date
Feb 1, 2026
Primary completion
Jul 1, 2026
Completion
Aug 1, 2026
Last update
Nov 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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