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Comparison of Tragal Perichondrium with Cubism Graft in type 1 Tympanoplasty in small to medium size Tympanic membrane perforations

Comparison of Tragal Perichondrium with Cubism graft in type 1 Tympanoplasty in small to medium size Tympanic membrane perforations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048690
Enrollment
40
Registered
2023-01-03
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: - Health Condition 2: H720- Central perforation of tympanic membrane

Interventions

Intervention1: CUBISM GRAFT: USE OF CUBISM GRAFT IN TYMPANOPLASTY DURATION - 12MONTHS Control Intervention1: TRAGAL PERICHONDRIUM: USE OF TRAGAL PERICHONDRIUM GRAFT IN TYMPANOPLASTY DURATION-12 MONTHS

Sponsors

MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED LOK NAYAK HOSPITAL
Lead Sponsor
DR HC TANEJA
Collaborator
DR RAVI MEHER
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.AGE GROUP:18 TO 60 YEARS. 2.SMALL(OCCUPYING AREA EQUIVALENT TO ONE QUADRANT) TO MEDIUM(OCCUPYING AREA EQUIVALENT TO TWO QUADRANTS) SIZED DRY CENTRAL PERFORATION OF PARS TENSA. 3.GOOD COCHLEAR RESERVE.

Exclusion criteria

Exclusion criteria: 1.ACTIVE MUCOSAL DISEASE 2.SQUAMOSAL TYPE OF CHRONIC OTITIS MEDIA 3.PREVIOUS HISTORY OF MIDDLE EAR SURGERY. 4.SUSPECTED OSSICULAR INVOLVEMENT WITH AIR BONE GAP >40dB. 5.COMPLICATED OTITIS MEDIA. 6.ANY PATIENT UNFIT FOR SURGERY DUE TO GENERAL/SYSTEMIC CONDITION.

Design outcomes

Primary

MeasureTime frame
CLOSURE OF TYMPANIC MEMBRANE PERFORATION VISUALIZED ON OTOSCOPY/ENDOSCOPY.Timepoint: 12 MONTHS—

Secondary

MeasureTime frame
IMPROVEMENT IN HEARING AS INDICATED BY CLOSURE OF AIR BONE GAPTimepoint: 12 MONTHS—

Countries

India

Contacts

Public ContactDR HC TANEJA

MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED LOK NAYAK HOSPITAL

taneja_hc@yahoo.com9899895712

Outcome results

None listed

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