| CTRI Number |
CTRI/2026/01/100793 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of platelet-rich blood products in improving the success rate of tympanoplasty in adult CSOM patients. |
|
Scientific Title of Study
|
Efficacy of Autologous Platelet Rich Plasma Versus Platelet Rich Fibrin Augmented Tympanoplasty: A Randomized comparative study of graft uptake, hearing improvement and Complications in Adult Patients Of CSOM in A tertiary Care Centre in Jharkhand. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nihar Topno |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Memorial Medical College and Hospital, Jamshedpur |
| Address |
Department of ENT
Mahatma Gandhi Memorial Medical College and Hospital,
Dimna Road, Mango, Jamshedpur.
Mahatma Gandhi Memorial Medical College and Hospital,
Dimna Road, Mango, Jamshedpur.
Purbi Singhbhum
JHARKHAND
831020
India |
| Phone |
7465928991 |
| Fax |
|
| Email |
nihartopno20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nihar Topno |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Memorial Medical College and Hospital, Jamshedpur |
| Address |
Department of ENT
Mahatma Gandhi Memorial Medical College and Hospital,
Dimna Road, Mango, Jamshedpur.
Mahatma Gandhi Memorial Medical College and Hospital,
Dimna Road, Mango, Jamshedpur.
Purbi Singhbhum
JHARKHAND
831020
India |
| Phone |
7465928991 |
| Fax |
|
| Email |
nihartopno20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nihar Topno |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Memorial Medical College and Hospital, Jamshedpur |
| Address |
Department of ENT
Mahatma Gandhi Memorial Medical College and Hospital,
Dimna Road, Mango, Jamshedpur.
Mahatma Gandhi Memorial Medical College and Hospital,
Dimna Road, Mango, Jamshedpur.
Purbi Singhbhum
JHARKHAND
831020
India |
| Phone |
7465928991 |
| Fax |
|
| Email |
nihartopno20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multi Disciplinary Research Unit, Mahatma Gandhi Memorial Medical College, Jamshedpur, Jharkhand. |
|
|
Primary Sponsor
|
| Name |
Multi-Disciplinary Research Unit |
| Address |
Mahatma Gandhi Memorial Medical College,Dimna Road, Mango, Jamshedpur, Jharkhand. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nihar Topno |
Mahatma Gandhi Memorial Medical College and Hospital, Jamshedpur |
Department of ENT
Mahatma Gandhi Memorial Medical College and Hospital
Dimna Road Mango Jamshedpur
Purbi Singhbhum
JHARKHAND |
7465928991
nihartopno20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Memorial Medical College Hospital, Jamshedpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous Platelet Rich Fibrin |
Gel foam soaked with Platelet Rich Fibrin will be applied over graft flap assembly during tympanoplasty. |
| Intervention |
Autologous Platelet Rich Plasma |
Gel foam soaked with Platelet Rich Plasma will be applied over graft flap assembly during tympanoplasty. |
| Comparator Agent |
Control Group standard treatment |
Plain gel foam will be applied over graft flap assembly during tympanoplasty. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases of chronic otitis media [COM], inactive mucosal disease with central perforation and conductive hearing loss in the age group of 18–55 years of both genders.
2.Dry ear without discharge for at least 6 to 8 weeks
3.Hearing loss will be less than 60 dB.
4.Patients consented for study.
|
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years and more than 55 years.
2.Active ear disease.
3.Total perforation.
4.Marginal perforation.
5.Tympanosclerosis.
6.Cholesteatoma.
7.Otosclerosis.
8.Atopic ear conditions.
9.Middle ear mucosa congested or polypoidal.
10.Revision surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Graft Uptake |
Post operative 3 weeks
Post operative 6 weeks
Post operative 3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hearing improvement |
Post operative 3 Months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized participant- and outcome-assessor-blind, parallel-group trial of the efficacy of autologous platelet-rich plasma versus platelet-rich fibrin-augmented tympanoplasty, comparing graft uptake, hearing improvement, and complications in CSOM patients. It will be conducted at MGM Medical College and Hospital, Jamshedpur, Jharkhand. The primary outcome measure will be graft uptake, which will be checked at 3 weeks, 6 weeks, and 3 months after surgery. The secondary outcome will be a postoperative hearing improvement assessment at 3 months. |