Skip to content

A study to compare graft uptake in surgery of tympanic membrane perforations by adding a blood product from the patients own blood to help promote healing during the surgery.

A Randomised controlled trial on the efficacy of topical application of autologous Platelet Rich Plasma(PRP) on graft uptake rate in adults undergoing Type 1 Tympanoplasty for inactive COM mucosal disease

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017468
Enrollment
80
Registered
2019-02-05
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: H720- Central perforation of tympanic membrane

Interventions

Intervention1: Type 1 Tympanoplasty: Standard surgery for mucosal type of inactive Chronic Otitis Media. Done using a post aural route and temporalis fascia graft Control Intervention1: Type 1 Tympano

Sponsors

Dr Rakesh Datta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All cases of Chronic Otitis Media(COM) Mucosal type needing Type 1 tympanoplasty 2.Dry central perforation from last 3 months 3.Healthy middle ear mucosa

Exclusion criteria

Exclusion criteria: 1.COM Squamous 2.Active ear discharge 3.Ossicular chain defect/pathology 4.Presence of overt complications of COM 5.Revision surgery of COM

Design outcomes

Primary

MeasureTime frame
Tympanoplasty Graft Uptake RateTimepoint: 03 Months Post operative

Secondary

MeasureTime frame
Hearing loss as judged by Pure TOne audiometryTimepoint: 03 months post operative

Countries

India

Contacts

Public ContactAkash

Armed Forces Medical College (AFMC)

Rakeshdatta@gmail.com7508468671

Outcome results

None listed

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