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NCT05086718 Clinical Trial

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

Tympanic Membrane Perforation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05086718
Other study ID # RRB/531/CMH Quetta
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date September 30, 2022

Study information
Verified date October 2021
Source Combined Military Hospital Quetta
Contact Zeeshan Ayub, FCPS
Phone 03215233648
Email zeeshanent@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date September 30, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Endoscopic ear surgery
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.

Locations
Country Name City State
Pakistan CMH Quetta Quetta Balochistan

Sponsors (1)
Lead Sponsor Collaborator
Combined Military Hospital Quetta

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Akyigit A, Sakallioglu O, Karlidag T. Endoscopic tympanoplasty. J Otol. 2017 Jun;12(2):62-67. doi: 10.1016/j.joto.2017.04.004. Epub 2017 Apr 28. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Successful air bone gap closure on pure tone audiometry Three 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. Three months
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