| CTRI Number |
CTRI/2021/10/037273 [Registered on: 12/10/2021] Trial Registered Prospectively |
| Last Modified On: |
11/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [PLATELET RICH PLASMA] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Platelet-Rich Plasma (PRP) in tonsillectomy. |
|
Scientific Title of Study
|
EFFICACY OF AUTOLOGOUS PLATELET RICH PLASMA IN TONSILLECTOMY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR V SRINIVASA |
| Designation |
Professor |
| Affiliation |
vinayaka missions research foundation |
| Address |
DEPARMENT OF ENT
VINAYAKA MISSIONS MEDICAL COLLEGE
KARAIKAL
Karaikal
PONDICHERRY
609609
India |
| Phone |
9842774997 |
| Fax |
|
| Email |
vemsrigeenan2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR V SRINIVASA |
| Designation |
professor |
| Affiliation |
vinayaka missions research foundation |
| Address |
DEPARMENT OF ENT
VINAYAKA MISSIONS MEDICAL COLLEGE
KARAIKAL
Karaikal
PONDICHERRY
609609
India |
| Phone |
9842774997 |
| Fax |
|
| Email |
vemsrigeenan2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AN MUTHU RAMANATHAN |
| Designation |
POST GRADUATE |
| Affiliation |
vinayaka missions research foundation |
| Address |
DEPARTMENT OF ENT
VINAYAKA MISSIONS MEDICAL COLLEGE
KARAIKAL
Karaikal
PONDICHERRY
609609
India |
| Phone |
7010996587 |
| Fax |
|
| Email |
drmuthu.an@gmail.com |
|
|
Source of Monetary or Material Support
|
| vinayaka missions medical college |
|
|
Primary Sponsor
|
| Name |
VINAYAKA MISSIONS MEDICAL COLLEGE |
| Address |
Keezhakasakudymedu
karaikal
609609 |
| Type of Sponsor |
Private medical college |
|
|
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 V SRINIVASA |
VINAYAKA MISSIONS MEDICAL COLLEGE |
ROOM NO 11,DEPARTMENT OF ENT
VINAYAKA MISSIONS MEDICAL COLLEGE
KARAIKAL
609609
Karaikal
PONDICHERRY |
9842774997
vemsrigeenan2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J039||Acute tonsillitis, unspecified. Ayurveda Condition: -, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP 1 PLATELET RICH PLASMA |
autologous platelet-rich plasma freshly prepared was used to layer the tonsillar fossa immediately after the surgery. Patients were then evaluted for post operative pain and healing and recovery time on 0 day 1st day 2nd day 3rd day
On follow up on 7thday and 14thday.
|
| Comparator Agent |
GROUP 2 CONTROL GROUP |
platelet rich plasma is not given to one group of tonsillectomy patients and Patients were then evaluted for post operative pain and healing and recovery time on 0 day 1st day 2nd day 3rd day
On follow up on 7thday and 14thday.
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing tonsillectomy under general
anaesthesia who gave their consent |
|
| ExclusionCriteria |
| Details |
1.history of dysphagia or odynophagia due to causes other than tonsillitis.
2.patients suffering from bleeding disorders.
3.patients undergoing tonsillectomy for reasons other than chronic tonsillitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To investigate the effectiveness of Platelet-rich plasma application in healing of the tonsillar fossa. |
on 0 day ,1st day, 2nd day ,3rd day ,7th day and 14th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the effectiveness of Platelet-rich plasma in reducing post-operative pain.
2.To assess the number of days required for the patient to return to normal activities |
on 0 day ,1st day, 2nd day ,3rd day ,7th day and 14th day |
|
|
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)
|
15/10/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study is to investigate the effect on post-operative pain and enhancement of healing and recovery time following application of autologous Platelet-Rich Plasma (PRP) in the tonsillectomy fossae.
40 patients will be included in this study The patients were divided into 2 groups of 20 patients each
PRP GROUP Autologous platelet-rich plasma freshly prepared is used to layer the tonsillar fossa immediately after the surgery and patients were then evaluated for post operative pain and healing and recovery time on postoperative 0 day 1st day 2nd day 3rd day 7th day and 14thday
CONTROL GROUP Platelet rich plasma will not be given to one group of tonsillectomy patients and patients were then evaluated for post operative pain and healing and recovery time on postoperative 0 day 1st day 2nd day 3rd day 7thday and 14th day |