Comparing the healing of ear drum using Hyaluronic acid with Gel foam

Comparison of the outcomes of gel foam myringoplasty with hyaluronic acid myringoplasty in mucosal chronic otitis media. - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094327

Enrollment

Registered

2025-09-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H661- Chronic tubotympanic suppurative otitis media

Interventions

Intervention1: Hyaluronic acid: 2.5% of 1 ml hyaluronic acid gel application in middle ear and External Auditory Canal durig graft placement during myringoplasty Control Intervention1: Gel foam: Gel f

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 .Timepoint: Ear examination done at 15 days,1 month and 3 month.Pure tone audiometry test done at 1 month and 3 month follow up	—

Measure

Time frame

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 .Timepoint: 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

Measure	Time frame
1.Ear discharge,infection after procedure 2.Pain in ear canal after procedure 3.Any other complication of procedureTimepoint: Ear examination done at 15 days,1 month and 3 month	—

Countries

India

Contacts

Public ContactDR VIKRAM K BHAT

Karnataka Medical College and Research Institute

vikram.ent@gmail.com7899610213

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026