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Comparison between two grafts in treatment of ear perforation

A comparative study of temporalis fascia and fascia lata grafts in type 1 tympanoplasty

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032179
Enrollment
50
Registered
2021-03-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Type-1 tympanoplasty: On 50 patient with perforation in ear, typeb1 tympanoplasty will be done Control Intervention1: Temporalis fascia and fascia lata grafts: In this study, there will

Sponsors

Department of ENT
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Patient who gives informed and written consent. -Patient having dry ear for atleast 6 weeks -Patient having normal cochlear reserve

Exclusion criteria

Exclusion criteria: -Patient with active suppurative otitis media - Patient with sensoryneural hearing loss element - Patient with any CSOM complication, external ear pathology, sinonasal pathology. - Patient with obvious ossicular dysfunction

Design outcomes

Secondary

MeasureTime frame
- Graft success and failure with respect to graft material -Total hearing gain in successful graft taken up -Graft success with respect to a. size of perforation b. age and sex distribution c. duration of the diseaseTimepoint: 2 year

Primary

MeasureTime frame
- Graft success and failure with respect to graft material -Total hearing gain in successful graft taken up -Graft success with respect to a. size of perforation b. age and sex distribution c. duration of the diseaseTimepoint: 2 year

Countries

India

Contacts

Public ContactDr Senbagadevi S

Head of Department in Otorhinolaryngology, Sir T hospital, Bhavnagar

sushilkgjhatanmay@gmail.com9426909700

Outcome results

None listed

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