| CTRI Number |
CTRI/2025/03/082678 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Platelet-Rich Plasma as an Adjunct in Tympanoplasty: Evaluating Graft Uptake and Healing in Large Perforations |
|
Scientific Title of Study
|
Effect of platelet rich plasma in the healing and outcome of large perforation of tympanic membrane |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Kumar |
| Designation |
Postgraduate |
| Affiliation |
Sri ramachandra medical college and hospital |
| Address |
Sri Ramachandra Institute of Higher Education and Research 1 Mount Poonamallee Road Sri Ramachandra Nagar Ramachandra Nager
Department of ENT sri ramachandra medical college and hospital
Chennai
TAMIL NADU
600116
India |
| Phone |
8610321188 |
| Fax |
|
| Email |
nikhilkumar1206@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nikhil Kumar |
| Designation |
Postgraduate |
| Affiliation |
Sri ramachandra medical college and hospital |
| Address |
Sri Ramachandra Institute of Higher Education and Research 1 Mount Poonamallee Road Sri Ramachandra Nagar Ramachandra Nager
Pg medical boys hostel Room G-227
Chennai
TAMIL NADU
600116
India |
| Phone |
8610321188 |
| Fax |
|
| Email |
nikhilkumar1206@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil Kumar |
| Designation |
Postgraduate |
| Affiliation |
Sri ramachandra medical college and hospital |
| Address |
Sri Ramachandra Institute of Higher Education and Research 1 Mount Poonamallee Road Sri Ramachandra Nagar Ramachandra Nager
Pg medical boys hostel Room G-227
Chennai
TAMIL NADU
600116
India |
| Phone |
8610321188 |
| Fax |
|
| Email |
nikhilkumar1206@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nikhil kumar |
| Address |
NO 8 AROW NEW CITY , KOLATHUR , PUTHAGARAM , CHENNAI - 600099 |
| Type of Sponsor |
Other [CASH ] |
|
|
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 |
| nikhil kumar |
Sri Ramachandra medical college |
Sri Ramachandra Institute of Higher Education and Research , Porur
Chennai
TAMIL NADU |
8610321188
nikhilkumar1206@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional researchethics committee |
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 |
Platelet rich plasma |
blood drawn from the patient is centrifuged and the platelet rich plasma is put over the graft after routine tympanoplasty |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients consenting to the study
patients with large central perforation of the tympanic membrane |
|
| ExclusionCriteria |
| Details |
patients not consenting to the study
patients with comorbid conditions like diabetes , hypertension, thyroid abnormality, retrovirus and hepatitis |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BETTER GRAFT UPTAKE COMPARED TO NON PRP PROCEDURE |
NIL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| LESSER COMPLICATION RATE COMPARED TO CONVENTIONAL PROCEDURE |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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)
|
Open to Recruitment |
| 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
|
TO ASSES THE GRAFT UPTAKE AND HEALING WITH PLATELET RICH PLASMA IN TYMPANOPLASTY SURGERY , POST PROCEDURE PATIENT WILL BE FOLLOWED UP FOR UPTO 3 MONTHS AND AFTER WHICH OUTCOMES WILL BE ASSES BY GRAFT UPTAKE AND PURE TONE AUDIOGRAM VALUES WITH PRE OPERATIVE VALUES |