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A study to see whether adding platelet-rich fibrin improves healing and hearing after ear drum repair surgery in patients with chronic ear infection

A Comparison of Outcomes of Type 1 Tympanoplasty With or Without Autologous Platelet Rich Fibrin after Three Months in Cases of Mucosal Type of Chronic Otitis Media at a Tertiary Care Centre: A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109539
Enrollment
80
Registered
2026-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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: Type 1 Tympanoplasty with Autologous Platelet-Rich Fibrin (PRF): The intervention arm includes patients undergoing type 1 tympanoplasty with temporalis fascia graft along with intraoper

Sponsors

maharaja agrasen medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients in age group of 18-40 years 2)Patients with mucosal type of COM without any complications 3)Patients with dry ear (no discharge) for more than 6 weeks 4)Patient with mild to moderate conductive hearing loss (upto 55 db loss) 5)Patients willing to participate in the study

Exclusion criteria

Exclusion criteria: 1)Patients with squamosal type of COM 2)Patients with wet ear (mucoid or mucopurulent discharge) 3)Patients with mixed hearing loss 4)Patients with known co-morbidities like Diabetes Mellitus, Hypertension, Tuberculosis etc. 5) Revision ear surgeries 6)Patients with Traumatic perforation

Design outcomes

Primary

MeasureTime frame
1)Status of graft uptake at 3-month follow up Timepoint: 1)Status of graft uptake at 3-month follow up—

Secondary

MeasureTime frame
2)Hearing gain assessed by audiometry at 3 months post-surgeryTimepoint: Hearing gain assessed by audiometry at 3 months post-surgery—

Countries

India

Contacts

Public Contactpooja maheshwari

maharaja agrasen medical college, agroha

anilkumarchahar1980@gmail.com8570043729

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026