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Study to assess the efficacy of Graft material for Myringoplasty between ttemporalis fascia vs Dehydrated Human Amniotic Membrane

Comparative Study of Efficacy of Temporalis Fascia vs Dehydrated Human Amniotic Membrane as Graft Material in Myringoplasty- A randomized controlled trial ?. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064868
Enrollment
100
Registered
2024-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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: Myringoplasty using two different graft material: Myringoplasty is known to be done with different graft materials. in this study a comparative outcome analysis will be done between aut

Sponsors

College of Medicine and Sagore Dutta Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (a) Patients aged 15 years to 50 years (b)Patients having ‘Quiescent Mucosal type’ of Chronic Otitis media

Exclusion criteria

Exclusion criteria: (a) Patients having ‘Squamosal type’ of Chronic Otitis media (b) Patients having ‘Mixed deafness’ or ‘Sensorineural’ deafness (c) Patients having ossicular damage on examination under microscope (EUM) (d) Patients having vestibular symptom (e) Patients having any suggestive complication of otitis media (f) Very low general condition/ severe medical disability/ unsound mental status (g) Patients having persistent infective focus in ENT region, clinically (h) Patients suspected to suffer from chronic specific infective/ Granulomatous diseases eg Tuberculosis, Leprosy etc. (i) Non-cooperative patients

Design outcomes

Primary

MeasureTime frame
Complete healing and functional recovery of Tympanic membraneTimepoint: 6-12 weeks

Secondary

MeasureTime frame
Improvement of heariing and PQLITimepoint: six months to one year

Countries

India

Contacts

Public ContactAnup Kumar Das

College of medicine and Sagore Dutta Hospital

indranilsen.india@gmail.com9749283857

Outcome results

None listed

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