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Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap

Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media Without Posterior Meatal Flap

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05086718
Enrollment
300
Registered
2021-10-21
Start date
2021-09-01
Completion date
2022-09-30
Last updated
2021-10-21

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

Conditions

Tympanic Membrane Perforation

Brief summary

Composite Cartilage Perichondrium Graft for tympanoplasty in chronic suppurative otitis media (CSOM) Air Bone Gap (AB Gap) Closure will be taken as successful outcome Endoscopic technique without posterior meatal flap elevation

Detailed description

300 eligible cases of dry CSOM will under go Composite Cartilage Perichondrium Graft tympanoplasty. Air Bone Gap Closure will be taken as successful outcome. The procedure will employ endoscopic technique without posterior meatal flap elevation.

Interventions

Endoscopic approach without posterior meatal flap elevation will be employed in the ear with dry chronic suppurative otitis media. Tympanoplasty utilizing composite cartilage-fascia graft will be performed. After three months of time period successful outcome will be taken as closure of air bone gap on pure tone audiometry.

Sponsors

Combined Military Hospital Quetta
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

300 cases of dry perforation CSOM

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1. Both genders between 21 to 55 years 2. Dry chronic suppurative otitis media 3. Air bone gap between 15 to 25 Deci bel

Exclusion criteria

1. Discharging ear 2. Pediatric population 3. Ossicular Necrosis 4. Previous ear surgery

Design outcomes

Primary

MeasureTime frameDescription
Successful air bone gap closure on pure tone audiometryThree monthsThree months of endoscopic tympanoplasty using composite cartilage-fascia graft, pure tone audiometry will be carried out measuring both air and bone conduction. Successful outcome will be closure of the air bone gap as compared with pre surgery air bone gap.

Countries

Pakistan

Contacts

Primary ContactZeeshan Ayub, FCPS
zeeshanent@yahoo.com03215233648

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026