| CTRI Number |
CTRI/2017/04/008315 [Registered on: 07/04/2017] Trial Registered Prospectively |
| Last Modified On: |
03/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to study the efficacy of blood derived material in treating patients with ear drum perforation. |
|
Scientific Title of Study
|
A randomised control trial to assess efficacy of platelet rich fibrin in tympanoplasty. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Vallathukaran Mathew |
| Designation |
Junior Resident, MS Ent |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of ENT
Kasturba Medical College & Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8147983039 |
| Fax |
|
| Email |
nikhilvmathew91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipak Ranjan Nayak |
| Designation |
Professor and head of Unit 1, ENT |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of ENT
Kasturba Medical College & Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
drnent@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil Vallathukaran Mathew |
| Designation |
Junior Resident, MS Ent |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of ENT
Kasturba Medical College & Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8147983039 |
| Fax |
|
| Email |
nikhilvmathew91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal,Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Nikhil Vallathukaran Mathew |
| Address |
Kasturba Medical College
Manipal
Udupi -576104 |
| Type of Sponsor |
Other [] |
|
|
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 Nikhil Vallathukaran Mathew |
ENT department, 4th Floor,New OPD Block |
Kasturba Medical College
Manipal,
Udupi,
Karnataka - 576104
Udupi
KARNATAKA |
8147983039
nikhilvmathew91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Suppurative Otitis Media - Tubo Tympanic Disease(Inactive), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No additional material used |
Intraoperatively graft is used to close ear perforation without using any additional material |
| Intervention |
Platelet Rich Fibrin |
Used intraoperatively above the graft after closing ear perforation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Chronic Suppurative Otiti Media- Tubotympanic Disease(Inactive)
|
|
| ExclusionCriteria |
| Details |
Comorbities like Diabetes Mellitus, Hypertension, Bronchial Asthma, Tuberculosis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess to graft uptake following application of platelet rich fibrin. |
At end of 1 week, 1 month and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the rate of healing. |
At end of 1 week,1 month and 3 month |
| To assess the hearing improvement post tympanoplasty |
At end of 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/04/2017 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, single blinded, parallel group, single centre trial comparing the improved outcome with the use of platelet rich fibrin in Tympanoplasty ear surgery as compared with conventional technique without using the platelet rich fibrin.This study will be done for 15 month over 60 patients with chronic suppurative otitis media(Inactive) with no comorbidities. The primary outcome will measure the graft take up at 1st week, 1st month and 3rd month. The healing rate of of perforation and hearing improvement post tympanoplasty is also assessed at 3rd months.
|