A Clinical trial to study the efficacy of blood derived material in treating patients with ear drum perforation.

Not yet recruiting

• Conditions: Chronic Suppurative Otitis Media - Tubo Tympanic Disease(Inactive)

• Registration Number: CTRI/2017/04/008315
• Lead Sponsor: Dr Nikhil Vallathukaran Mathew

Brief Summary

This study is a randomised, single blinded, parallel group, single centre trial comparing the improved outcome with the use of platelet rich fibrin in Tympanoplasty ear surgery as compared with conventional technique without using the platelet rich fibrin.This study will be done for 15 month over 60 patients with chronic suppurative otitis media(Inactive) with no comorbidities. The primary outcome will measure the graft take up at 1st week, 1st month and 3rd month. The healing rate of of perforation and hearing improvement post tympanoplasty is also assessed at 3rd months.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-03-04
• Study Start: 2017-10-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Chronic Suppurative Otiti Media- Tubotympanic Disease(Inactive).

Exclusion Criteria

Comorbities like Diabetes Mellitus, Hypertension, Bronchial Asthma, Tuberculosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess to graft uptake following application of platelet rich fibrin.	At end of 1 week, 1 month and 3rd month

Secondary Outcome Measures

Name	Time	Method
To assess the rate of healing.	At end of 1 week,1 month and 3 month
To assess the hearing improvement post tympanoplasty	At end of 3 months

Trial Locations

Locations (1)

ENT department, 4th Floor,New OPD Block; 🇮🇳 Udupi, KARNATAKA, India

ENT department, 4th Floor,New OPD Block

🇮🇳Udupi, KARNATAKA, India

Dr Nikhil Vallathukaran Mathew

Principal investigator

8147983039

nikhilvmathew91@gmail.com