| CTRI Number |
CTRI/2024/12/078245 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| 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
|
Effectiveness of Platelet-Rich
Plasma in Comparison to Conventional Myringoplasty Procedure
|
|
Scientific Title of Study
|
Assessing the Effectiveness of Autologous Platelet-Rich
Plasma in Comparison to Conventional Myringoplasty Procedure:A Randomized
Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharan Prakash |
| Designation |
Post graduate |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
6361392845 |
| Fax |
|
| Email |
sharan.00100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NISHANTH SAVERY |
| Designation |
PROFESSOR |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9901515427 |
| Fax |
|
| Email |
docnishuu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NISHANTH SAVERY |
| Designation |
PROFESSOR |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9901515427 |
| Fax |
|
| Email |
docnishuu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
DrSharan Prakash |
| Address |
Opd Number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam |
| 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 Sharan Prakash |
Aarupadai Veedu Medical College and Hospital |
Opd Number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Pondicherry
607402
Pondicherry
PONDICHERRY |
6361392845
sharan.00100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical 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 |
Autologous Platelet Rich Plasma |
Use of autologous platelet rich plasma in myringoplasty |
| Comparator Agent |
Normal Saline |
Use of Normal Saline in myringoplasty |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All cases of tubotympanic type of chronic suppurative otitis media with perforation of
the tympanic membrane with dry ear for a period of 3 weeks before day of surgery.
2. No evidence of active infection in nose,throat or paranasal sinuses.
3. Includes patient in the age group of 15-70 years. |
|
| ExclusionCriteria |
| Details |
1. All cases of Attico antral type of CSOM.
2. Patients with age less than 15 years and more than 70 years of age.
3. Otogenic intra cranial complications in the past.
4. External ear infective condition.
5. Per operative ossicular discontinuity, fixed foot plate.
6. Patients with evidence of focal sepsis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tympanic membrane closure success rate assessed by otoscopy and
tympanometry at specified follow-up intervals (e.g., 6 weeks & 3 months postsurgery). |
at 6 weeks and 3 months post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in pure tone audiometry (PTA) thresholds,
postoperative complications (e.g.,graft displacement, infection), and patient reported
outcomes (e.g.,subjective hearing improvement, satisfaction with surgery).
|
Within 6 weeks and 3 months post surgery |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/12/2024 |
| 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="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - email me at sharan.00100@gmail.com
- For how long will this data be available start date provided 10-06-2026 and end date provided 25-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Myringoplasty, a surgical procedure aimed at repairing tympanic membrane perforations,
is crucial for restoring hearing and preventing middle ear infections. While conventional
techniques have been the mainstay for decades, emerging evidence suggests the potential
benefits of autologous platelet-rich plasma (PRP) in enhancing tissue healing and
regeneration. This randomized controlled trial (RCT) aims to assess the comparative
efficacy of PRP versus conventional myringoplasty in terms of surgical outcomes,
hearing improvement, and complication rates. By evaluating these two approaches head-
to-head, this study seeks to provide valuable insights into the potential role of PRP in
optimizing myringoplasty outcomes and advancing the field of otologic surgery. |