| CTRI Number |
CTRI/2020/04/024416 [Registered on: 01/04/2020] Trial Registered Prospectively |
| Last Modified On: |
09/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Analyse the Efficacy of Using Platelet-rich plasma taken from patient blood sample on Graft Uptake in Ear Surgery : A Randomized Control Trial |
|
Scientific Title of Study
|
Efficacy of Autologous Platelet-rich plasma on Graft Uptake in Myringoplasty : A Single Blinded Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vignesh |
| Designation |
Junior resident |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of ENT
Mahatma Gandhi Medical College and Research Institute,
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9940404119 |
| Fax |
|
| Email |
vickirv09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gopalakrishnan S |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of ENT
Mahatma Gandhi Medical College and Research Institute,
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894219519 |
| Fax |
|
| Email |
suriagk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vignesh |
| Designation |
MS Post graduate |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of ENT
Mahatma Gandhi Medical College and Research Institute,
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9940404119 |
| Fax |
|
| Email |
vickirv09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute,
Pillayarkuppam, Pondicherry-607402 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of ENT
Mahatma Gandhi Medical College and Research Institute,
Pillayarkuppam, Pondicherry-607402 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vignesh |
Mahatma Gandhi medical college and Research Institute |
Department of ENT
Mahatma Gandhi medical college and Research Institute
Pondicherry
PONDICHERRY |
9940404119
vickirv09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H729||Unspecified perforation of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Platelet rich plasma |
Patients blood sample will be taken to generate platelet rich plasma which will be kept over the middle ear mucosa and over the graft. |
| Comparator Agent |
Saline soaked gelfoam |
Saline soaked gelfoam will be kept over the middle ear mucosa and over the graft. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of chronic suppurative otitis Media |
|
| ExclusionCriteria |
| Details |
Patients with active infection, attico-antral disease, chronic granulomatous disease and tumors of the ear, co-morbidities like uncontrolled diabetes, previous history of Myringoplasty or mastoidectomy , contraindication to general anesthesia, patient who smoke
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Age,sex,graft uptake, percentage of perforation closure, audiology outcome |
3rd and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Graft uptake, percentage of perforation closure, audiological outcome |
3rd and 6th month |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is done to assess the Efficacy of Autologous platelet rich plasma on Graft Uptake in Myringoplasty in terms of percentage of perforation closure and audiological outcome. All patients with chronic suppurative otitis media between 18-55years of age will be included in the study to attain a sample size of 76 over a period of 18 months. |