Evaluation of the Effect of Platelet-rich Fibrin on the Outcomes of Tympanoplasty Using Temporalis Fascia Graft: A Randomized Clinical Trial

Randomized clinical trial; patients with tympanic membrane perforation, effect of Platelet-Rich Fibrin versus no PRF on graft uptake and hearing improvement after tympanoplasty using temporalis fascia graft.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240108060650N2

Enrollment

Registered

2025-09-05

Start date

2025-09-23

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

tympanic membrane perforation. Central perforation of tympanic membrane

Interventions

Intervention 1: Intervention group: In the intervention group, following tympanoplasty with temporalis fascia graft, PRF is used as an adjunct to accelerate the healing process. PRF is obtained from t

Eligibility

Sex/Gender

All

Age

15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Central tympanic membrane perforation larger than 25%. 2. No middle ear involvement on temporal bone CT. 3. No scutum erosion on CT scan. 4. Air–bone gap on audiogram less than 40 dB. 5. No active fungal otorrhea.

Exclusion criteria

Exclusion criteria: 1. Lack of consent to participate in the study 2. Immunodeficiency 3. Chronic diseases requiring corticosteroid therapy 4. Nasal polyposis and chronic rhinosinusitis (CRS)

Design outcomes

Primary

Measure	Time frame
Hearing threshold. Timepoint: At 1 month and 3 months follow-up. Method of measurement: audiometric testing.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKeyarmin Ghavam

Bagheiat-allah University of Medical Sciences

kagh7495@gmail.com+98 21 2213 4625

Outcome results

None listed

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