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A Study comparing the benefits of using Single and Double Layer Fascia Grafts in Tympanic Membrane Perforation Repair Surgery

A Study Comparing the outcomes of Double Layer Vs Single Layer Temporalis Fascia Graft in Type 1 Tympanoplasty for Subtotal and Anterior Perforations - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/096830
Enrollment
64
Registered
2025-11-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: H729- Unspecified perforation of tympanic membrane Health Condition 2: H729- Unspecified perforation of tympanic membrane

Interventions

Intervention1: Double Layer Temporalis Fascia Graft: Patient undergoing Type 1 Tympanoplasty with Double Layer Temporalis Fascia Graft in Subtotal and Anterior Perforations which will be done for 1 ye

Sponsors

Dr Asmit Bansal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient with inactive chronic otitis media (tubotympanic disease) ;Patient willing to participate in study,Patient with conductive Hearing Loss with AB Gap of less than 45dB;Subtotal/Anterior perforation in TM

Exclusion criteria

Exclusion criteria: Patient with recurrent chronic otitis media;Patient with central perforation with active discharge;Patient with Uncontrolled Diabetes Mellitus, Uncontrolled Hypertension and Bronchial Asthma and Tuberculosis ,Patient with mixed hearing loss

Design outcomes

Primary

MeasureTime frame
To compare the success rate of graft uptake between Double Layer versus Single Layer Temporalis Fascia GraftTimepoint: Once weekly for one month Fortnightly for three months Six months—

Secondary

MeasureTime frame
To Compare the hearing outcome in Double Layer vs Single Layer Temporalis GraftTimepoint: 6th week 3rd Month 6th Month—

Countries

India

Contacts

Public ContactDr Saquib Reyaz Khan

Varun Arjun Medical College and Rohilkhand Hospital

santhanakrishnan2709@gmail.com8940132448

Outcome results

None listed

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