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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/04/008315
Enrollment
60
Registered
2017-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Chronic Suppurative Otitis Media - Tubo Tympanic Disease(Inactive)

Interventions

Intervention1: Platelet Rich Fibrin: Used intraoperatively above the graft after closing ear perforation Control Intervention1: No additional material used: Intraoperatively graft is used to close ear

Sponsors

Dr Nikhil Vallathukaran Mathew
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Chronic Suppurative Otiti Media- Tubotympanic Disease(Inactive)

Exclusion criteria

Exclusion criteria: Comorbities like Diabetes Mellitus, Hypertension, Bronchial Asthma, Tuberculosis

Design outcomes

Primary

MeasureTime frame
To assess to graft uptake following application of platelet rich fibrin.Timepoint: At end of 1 week, 1 month and 3rd month—

Secondary

MeasureTime frame
To assess the hearing improvement post tympanoplastyTimepoint: At end of 3 months;To assess the rate of healing.Timepoint: At end of 1 week,1 month and 3 month—

Countries

India

Contacts

Public ContactNikhil Vallathukaran Mathew

Kasturba Medical College, Manipal

drnent@gmail.com

Outcome results

None listed

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