Use of Platelet Rich Fibrin sheet in repair of ear drum

Comparison of outcomes of myringoplasty using Temporalis fascia alone and Temporalis fascia with Platelet Rich Fibrin sheet - an Academic trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065658

Enrollment

128

Registered

2024-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: H661- Chronic tubotympanic suppurative otitis media

Interventions

Intervention1: Platelet Rich Fibrin Sheet for myringoplasty: Patients in intervention group while undergoing myringoplasty by post aural approach, using the underlay technique and temporalis fascia gr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of chronic otitis media with inactive mucosal type. 2.Patients with conductive hearing loss less than 40 db. 3.Age group between 18-60 Years. 4.Patients With inactive ear for atleast 6 weeks

Exclusion criteria

Exclusion criteria: 1.Patients with sensorineural hearing loss. 2.Pregnancy. 3.Patients with bleeding diathesis. 4.Patients with ossicular chain abnormalities. 5.Patients with mastoiditis, cholesteatoma and granulation tissue in middle ear. 6. Patients who refuses consent for PRF. 7.Patients with comorbidities like uncontrolled diabetes, hypertension, nasal allergies and COPD. 8.Patients with previous middle ear surgery, nasopharyngeal or skull base pathologies. 9. Patients coming for revision surgery.

Design outcomes

Primary

Measure	Time frame
graft uptakeTimepoint: 6 weeks	—

Secondary

Measure	Time frame
change in hearing thresholdTimepoint: 3 months	—

Countries

India

Contacts

Public ContactLalam Rama Varaha Rohini

AIIMS Mangalagiri

bakshi.s@aiimsmangalagiri.edu.in9698420998

Outcome results

None listed

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