Tympanic Membrane PerforationNCT07833670
Effectiveness of Silver Nitrate Cauterization vs Conservative Management in Tympanic Membrane Perforation Closure
A study testing 50% Silver Nitrate Cauterization in people with Tympanic Membrane Perforation, run by Muhammad Ali Javed at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- 50% Silver Nitrate Cauterization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Silver Nitrate Cauterization in the Closure of Tympanic Membrane Perforation
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.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- 50% Silver Nitrate Cauterization
- Keywords
- silver nitrate, Chemical cauterization, Tympanic Membrane Perforation, Spontaneous Healing, Gel foam Patching
- Medical subject headings
- Tympanic Membrane Perforation, Remission, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50% Silver Nitrate CauterizationDrug
Also called Chemical Cautery with Gel foam Patching
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tympanic Membrane Perforation Closure Rate
Proportion of participants achieving complete closure (healing) of the tympanic membrane without any residual defect, confirmed by otoscopic examination.
Measured: 4 weeks post-treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Feb 2026
- Primary completion1 Jul 2026
- Study completion1 Aug 2026
Why it stopped: Don't want to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either Group A (50% silver nitrate cauterization) or Group B (conservative management/spontaneous healing) and followed weekly for 4 weeks.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Ali Javed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Ali Javed, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833670
- Sponsor's protocol ID
- 4190/RTH,RWP.
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Silver Nitrate Cauterization in the Closure of Tympanic Membrane Perforation
- ClinicalTrials.gov ID
- NCT07833670
- Acronym / sponsor ID
- 4190/RTH,RWP.
- Conditions
- Tympanic Membrane Perforation
- Keywords
- silver nitrate, Chemical cauterization, Tympanic Membrane Perforation, Spontaneous Healing, Gel foam Patching
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Don't want to continue
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Muhammad Ali JavedUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to either Group A (50% silver nitrate cauterization) or Group B (conservative management/spontaneous healing) and followed weekly for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Group A - Silver Nitrate Cauterization | Experimental | Drug: 50% Silver Nitrate CauterizationMicroscopic 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 |
| Group B - Spontaneous Healing | No intervention | –Conservative management without active chemical or surgical intervention, observing for spontaneous healing over a 4-week period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- Age <18 years or >60 years
- Bilateral tympanic membrane perforations
- Perforation size >4 mm in diameter
- Discharging ear
- Edematous middle ear mucosa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50% Silver Nitrate CauterizationAlso: Chemical Cautery with Gel foam PatchingUnder 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. | Drug | Group A - Silver Nitrate Cauterization |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Don't want to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50% Silver Nitrate Cauterization in people with Tympanic Membrane Perforation, run by Muhammad Ali Javed at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Don't want to continue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tympanic Membrane Perforation Closure Rate (time frame: 4 weeks post-treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.