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Clinical Trials/CTRI/2017/04/008315
CTRI/2017/04/008315
Not yet recruiting
Not Applicable

A randomised control trial to assess efficacy of platelet rich fibrin in tympanoplasty.

Dr Nikhil Vallathukaran Mathew1 site in 1 country60 target enrollmentStarted: October 4, 2017Last updated:
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Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Nikhil Vallathukaran Mathew
Enrollment
60
Locations
1
Primary Endpoint
To assess to graft uptake following application of platelet rich fibrin.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Chronic Suppurative Otiti Media- Tubotympanic Disease(Inactive).

Exclusion Criteria

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

Outcomes

Primary Outcomes

To assess to graft uptake following application of platelet rich fibrin.

Time Frame: At end of 1 week, 1 month and 3rd month

Secondary Outcomes

  • 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)

Investigators

Sponsor
Dr Nikhil Vallathukaran Mathew
Sponsor Class
Other []

Study Sites (1)

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