Graft uptake and hearing outcomes in patient undergoing operation for perforation in tympanic membrane

Graft uptake and hearing outcomes in myringoplasty by conventional temporalis fascia underlay technique with and without addition of Platelet rich fibrin PRF A prospective randomized double blind study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077155

Enrollment

Registered

2024-11-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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 Health Condition 2: H628- Other disorders of external ear indiseases classified elsewhere Health Condition 3: H628- Other disorders of external ear indiseases classified elsewhere

Interventions

Intervention1: Platelet rich fibrin soaked gelfoam in Myringoplasty: To look for symptom relief, graft uptake and hearing outcomes in patient under going Myringoplasty surgery by conventional temporal

Eligibility

Inclusion criteria

Inclusion criteria: 1) patients diagnosed with chronic suppurative otitis media -safe type, inactive stage for atleast 3 months 2) no active foci of infection in nose and paranasal sinuses 3) normal eustachian tube function 4) adequate cochlear reserve 5) patients with traumatic tympanic membrane prforation

Exclusion criteria

Exclusion criteria: 1) patients with active infections, attico- antral disease, chronic granulomatous disease and tumours of ear 2) pregnant women 3) unstable hemodynamic disorders 4) comorbidities like uncontrolled diabetes mellitus with random blood sugar values of >200mg/ dl with oral or injectable antidiabetic drugs 5)patient with bleeding disorders 6) past history of ear surgery 7) when the other ear is dead or not suitable for hearing aid rehabilitation

Design outcomes

Primary

Measure	Time frame
To look for graft uptake in patients underwent Myringoplasty by conventional temporalis fascia underlay technique with or without addition of platelet rich fibrinTimepoint: otoendoscopy findings is done to assess the graft uptake in patient at interval of 1st,3rd and 6th month postoperatively	—

Secondary

Measure	Time frame
To look for hearing improvement in patients underwent Myringoplasty by conventional temporalis fascia underlay technique with or without addition of platelet rich fibrinTimepoint: Pure tone audiometry is done to assess the graft uptake in patient at interval of 1st,3rd and 6th month postoperatively	—

Countries

India

Contacts

Public ContactDr V Prabu

Sri venkateshwaraa medical college hospital and research centre

anbulavanya.131196@gmail.com9488456508

Outcome results

None listed

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