| CTRI Number |
CTRI/2024/07/070204 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare the usefulness of two Blood Products in the Surgery of Ear Drum Perforation |
|
Scientific Title of Study
|
A study to compare the outcomes of Type 1 Tympanoplasty with the Use of Platelet Rich Fibrin versus Platelet Rich Plasma |
| 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 VANSHIKA SINGHAL |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of ENT Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9068149983 |
| Fax |
|
| Email |
svanshika77@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhana Krishnan Kaliavardan |
| Designation |
HOD and Professor ENT |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of ENT
Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8940132448 |
| Fax |
|
| Email |
santhanakrishnan2709@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Saini |
| Designation |
Assistant Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of ENT
Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9997047550 |
| Fax |
|
| Email |
saurabh3064@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur |
|
|
Primary Sponsor
|
| Name |
Dr Vanshika Singhal |
| Address |
Varun Arjun Medical College,Banthra, Shahjahanpur, India, 242307 |
| Type of Sponsor |
Other [SELF] |
|
|
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 VANSHIKA SINGHAL |
Rohilkhanad Hospital, Banthra, Shahjahanpur |
Department of ENT Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH |
9068149983
svanshika77@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, VAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H729||Unspecified perforation of tympanic membrane, (2) ICD-10 Condition: H729||Unspecified perforation of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Platelet Rich Fibrin |
Patients Undergoing Type 1 Tympanoplasty With The Use Of Platelet Rich Fibrin Which Will Be Done For 1 Year |
| Comparator Agent |
Platelet Rich Plasma |
Patients Undergoing Type 1 Tympanoplasty With The Use Of Platelet Rich Plasma Which Will Be Done For 1 Year
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted and willing for the procedure
Patients with Chronic Otitis Media Tubotympanic Type
Patients with conductive hearing loss less than 40db
Dry ear for atleast 6 weeks
|
|
| ExclusionCriteria |
| Details |
Patients with Uncontrolled DM SHTN Bleeding Diathesis CAD
Patients with mixed hearing loss
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the graft uptake in type 1 tympanoplasty using Temporalis Fascia with PRF and with the application of PRP |
Once weekly for one month
Fortnightly for three months
Six months
ELVE MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the hearing outcomes in type 1 tympanoplasty using Temporalis Fascia with PRF & with the application of PRP
To assess the complications of applications of PRF & PRP in type 1 tympanoplasty
|
Once weekly for one month
Fortnightly for three months
Six months
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [3196vanshika@gmail.com].
- For how long will this data be available start date provided 01-07-2024 and end date provided 01-07-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The study " A study to compare the outcomes of Type 1 Tympanoplasty
with the use of Platelet Rich Fibrin versus Platelet Rich Plasma "
will be Conducted in department of Otorhinolaryngology , Varun Arjun Medical
College and Rohilkhand Hospital, Banthra, Shahjahanpur, Uttar Pradesh 242307
A. The study will be conducted
on subjects having tympanic membrane perforation attending the
Outpatient clinic in department
of Otorhinolaryngology , Varun Arjun Medical College and
Rohilkhand Hospital, Banthra, Shahjahanpur,
Uttar Pradesh based on inclusion and exclusion
Criterias
B. All patients selected for the
study will undergo detailed history taking and written informed
Consent
C. Otorhinolaryngology
assessment
D. Laboratory assessment
E. Patients will be admitted one
day before the surgery
F. Patients will be allocated
randomly into 2 groups
Group A :- Patients undergoing Type
1 Tympanoplasty with Platelet Rich Fibrin
Group B :- Patients undergoing Type
1 Tympanoplasty with Platelet Rich Plasma
|