| CTRI Number |
CTRI/2025/09/094327 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing the healing of ear drum using Hyaluronic acid with Gel foam |
|
Scientific Title of Study
|
Comparison of the outcomes of gel foam myringoplasty with hyaluronic acid myringoplasty in mucosal chronic otitis media. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amrith Smirk |
| Designation |
Post graduate |
| Affiliation |
Karnataka Medical College and Research Institute |
| Address |
Dr Amrith Smirk
Post graduate
Department of ENT
Karnataka Medical College and Research Institute, Vidyanagar,Hubli
Dharwad
Karnataka
India
Dharwad
KARNATAKA
580032
India |
| Phone |
7090131954 |
| Fax |
|
| Email |
amrithsmirk@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIKRAM K BHAT |
| Designation |
Professor and Head of Department |
| Affiliation |
Karnataka Medical College and Research Institute |
| Address |
Dr Vikram K Bhat
Professor and Head Department of ENT
Karnataka Medical College and Research Institute Vidyanagar,Hubli
Dharwad
Karnataka
India
580032
Dharwad
KARNATAKA
580032
India |
| Phone |
7899610213 |
| Fax |
|
| Email |
vikram.ent@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIKRAM K BHAT |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Karnataka Medical College and Research Institute |
| Address |
Professor and Head Department of ENT
Karnataka Medical College and Research Institute Vidyanagar,Hubli
Dharwad
Karnataka
India
580032
Dharwad
KARNATAKA
580032
India |
| Phone |
7899610213 |
| Fax |
|
| Email |
vikram.ent@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Medical College and Research Institute , Vidyanagar,Hubli,Dharwad, Karnataka, India,
Pin- 580021 |
|
|
Primary Sponsor
|
| Name |
Dr Vikram K Bhat |
| Address |
Professor and Head of department,ENT
Karnataka Medical College and Research Institute ,Vidyanagar , Hubli, Dharwad
India
580021 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amrith Smirk |
Karnataka Medical College And Research Institute |
Department of ENT
Room number 306
Dharwad
KARNATAKA |
7090131954
amrithsmirk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gel foam |
Gel foam placement in middle ear and External Auditory Canal during myringoplasty |
| Intervention |
Hyaluronic acid |
2.5% of 1 ml hyaluronic acid gel application in middle ear and External Auditory Canal durig graft placement during myringoplasty |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Inactive chronic otitis media with medium or large tympanic membrane
2.Central perforation of pars tensa
3.Age above 12 years
4.Non healing traumatic perforation |
|
| ExclusionCriteria |
| Details |
1.Marginal perforation in pars tensa
2.Pus or granulation in middle ear
3.Stenotic external auditory canal
4.Squamosal chronic otitis media
5.Tympanosclerosis
6.Immunocompromised patients
7.Complicated chronic otitis media
8.Non functional eustachian tube
9.Ossicular erosion and discontinuity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare reduction in size of perforation of tympanic membrane after myringoplasty before or after surgery between gel foam myringoplasty and hyaluronic acid myringoplasty.
2.To compare hearing gain or loss after procedure between 2 groups
3.To estimate approximate time taken for healing of tympanic membrane . |
Ear examination done at 15 days,1 month and 3 month.Pure tone audiometry test done at 1 month and 3 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Ear discharge,infection after procedure
2.Pain in ear canal after procedure
3.Any other complication of procedure |
Ear examination done at 15 days,1 month and 3 month |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amrithsmirk@gmail.com].
- For how long will this data be available start date provided 02-09-2025 and end date provided 21-08-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Hyaluronic acid is natural high molecular weight substance has the property of tissue repair and inflammation.It stimulates the healing of tympanic membrane . Study compares the healing of tympanic membrane perforation with hyaluronic acid and gel foam myringoplasty.
This is non randomised experimental study . Study analyses outcome of closure of tympanic membrane ,difference in pure ton average , complications and effects of procedure . |