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A Study to compare the Effect of closing the Hole in the Ear Drum using cartilage and fascia.

The Comparison of Tympnoplasty with Temporalis Fascia Graft Versus Cartilage Composite Graft A Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/08/015343
Enrollment
60
Registered
2018-08-14
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: H663- Other chronic suppurative otitis media

Interventions

Intervention1: Tympanoplasty (surgical): It involves the use of normal fascia graft in one group and use of composite cartilage in another group in tympanoplasty surgery. Intervention2: Tympanoplasty

Sponsors

Dr Shruthi Sreekumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.patients with anterior perforation,eustitian tube dysfunction,recurrent perforation 2.patients who are primary tympanoplasty cases with subtotal or large perforation. 3.patients diagnosed with CSOM Mucosal Type 4.patients with atleast 3 weeks dry period.

Exclusion criteria

Exclusion criteria: 1.patients with active infection. 2.Unsafe type of CSOM 3.patients having discharge ear.

Design outcomes

Primary

MeasureTime frame
Post operative outcomes assesed 1)Epithelialisation Of Graft 2)Graft Displacement 3)Rinnes Test 4)Webbers Test 5)Perforation Closure 6)Overall OutcomeTimepoint: Post operative assesments on 1.8 th day 2.15 th day 3.30 th day 4.45 th day 5.60 th day 6.75 th day 7.90 th day—

Secondary

MeasureTime frame
Hearing improvement which is assessed by Pure Tone AudiometryTimepoint: 60 th Post Operative Day—

Countries

India

Contacts

Public ContactDr CRK Balaji

SRM General Hospital SRM University

entpurush@gmail.com9840723243

Outcome results

None listed

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