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A Clinical trial to study the effects of using Plasma Rich Platelets in improving the outcomes of surgery during the repair of ear drum

A Comparative Study on Effectiveness of Autologous Platelet Rich Plasma Usage in Myringoplasty - A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/015103
Enrollment
60
Registered
2018-07-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- chronic suppurative otitis media

Interventions

Intervention1: Myringoplasty with usage of autologous Platelet Rich Plasma: All the patients with Chronic otitis media inactive mucosal disease (Central Perforation with dry ear) without discharge for

Sponsors

Preethy Joephine Kennedy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Chronic otitis media inactive mucosal disease (central perforation with dry ear) without discharge for at least 6 to 8 weeks

Exclusion criteria

Exclusion criteria: 1 Children below 18 years of age. 2 Active ear disease. 3 Atopic ear conditions. 4 Diabetes mellitus 5 Other systemic illness like autoimmune disease, active neoplastic disease. 6 Patient on immunosuppressant drugs.

Design outcomes

Primary

MeasureTime frame
Post operative outcomes assessed 1 Epithelialisation of graft 2 Uniform adherence of graft with tympanomeatal flap 3 graft displacement 4 Discharge 5 Rinnes test 6 Webers test 7 Overall outcome Timepoint: Post operative assessment on 1 8th day 2 15th day 3 30th day 4 45th day 5 60th day 6 75th day 7 90th day—

Secondary

MeasureTime frame
Hearing improvement which will be assessed by Pure Tone AudiometryTimepoint: 60th day post operative day—

Countries

India

Contacts

Public ContactDr CRK Balaji

SRM Medical College and Research Centre

entpurush@gmail.com9495241741

Outcome results

None listed

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