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Effectiveness of platelet rich fibrin (a blood product - derived from patients own blood) on complete repair of perforation in eardrum (tympanic membrane) on using along with surgery (type 1 Tympanoplasty).

Efficacy of Autologous Platelet Rich Fibrin (PRF) on successful closure rate in Type 1 Tympanoplasty : Open label randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068565
Enrollment
50
Registered
2024-06-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: H720- Central perforation of tympanic membrane

Interventions

Intervention1: Platelet rich fibrin (PRF) in Type 1 tympanoplasty: Temporalis fascia placed beneath TM flap platelet rich Fibrin (PRF) membrane will be , placed over the tympanomeatal flap layer then

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age from 18 to 65 , inactive chronic otitis media mucosal type, hearing less than 50 db, unilateral case of chronic suppurative otitis media , Dry from last 4 weeks

Exclusion criteria

Exclusion criteria: Chronic otitis media squamous , Hearing loss more than 50 db , patient with active discharge , revision tympanoplasty , any co-morbidities like DM .

Design outcomes

Primary

MeasureTime frame
To study the successful closure rate (complete graft uptake and healing of perforation) in experimental group (Type 1 tympanoplasty with Platelet rich fibrin) and control group (Type 1 tympanoplasty without Platelet rich fibrin).Timepoint: Follow up the patients at 1,3and 6 months post intervention and observe for Graft uptake â?? Full closure/ Residual perforation.

Secondary

MeasureTime frame
To assess healing time in repair of perforation To assess hearing outcome in term of A-B gap closureTimepoint: 1,3and 6 months

Countries

India

Contacts

Public ContactDr Mehul Barfa

AIIMS , Raipur

sharmisthachakravarty@yahoo.com9163505756

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026