| CTRI Number |
CTRI/2026/01/101406 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of silastic sheet placement in reducing pain after ear surgery |
|
Scientific Title of Study
|
SILASTIC SHEET INTERPOSITIONING FOR PREVENTION OF CRANIOFACIAL PAIN SECONDARY TO HARVESTING OF TEMPORALIS FASCIA IN MYRINGOPLASTY |
| 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 V Srinivasa |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Missions University: Vinayaka Missions Research Foundation (Deemed to be University) |
| Address |
ENT Department
Vinayaka missions medical college and hospital
Keezhakasakudimedu
Karaikal
PONDICHERRY
609609
India |
| Phone |
09842774997 |
| Fax |
|
| Email |
vemsrigeenan2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Vishnupriya |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions University: Vinayaka Missions Research Foundation (Deemed to be University) |
| Address |
ENT Department
Vinayaka missions medical college and hospital
Keezhakasakudimedu
Karaikal
PONDICHERRY
609609
India |
| Phone |
08129846364 |
| Fax |
|
| Email |
drsvishnupriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Vishnupriya |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions University: Vinayaka Missions Research Foundation (Deemed to be University) |
| Address |
ENT Department
Vinayaka missions medical college and hospital
Keezhakasakudimedu
Karaikal
PONDICHERRY
609609
India |
| Phone |
08129846364 |
| Fax |
|
| Email |
drsvishnupriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| vinayaka missions research foundation Student Research Grant |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions research foundation |
| Address |
Vinayaka missions medical college and hospital
Keezhakasakudimedu, karaikal , puducherry PIN 609609 |
| Type of Sponsor |
Research institution |
|
|
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 S Vishnupriya |
VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF OTORHINOLARYNGOLOGY/ICU BLOCK/ ROOM NO 10
Karaikal
PONDICHERRY |
8129846364
drsvishnupriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| vVINAYAKA MISSIONS INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
myringoplasty without silastic sheet |
myringoplasty is performed using temporalis fascia graft without interpositioning of silastic sheet at donor site. |
| Intervention |
silastic sheet interpositioning during myringoplasty |
silastic sheet will be interpositioned at temporalis facia graft site and kept in position with the use of 3-0 vicryl with the aim of preventying postoperative craniofacial pain. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Tubo tympanic type of CSOM
Ear to be operated should be dry for at least 4 weeks prior to surgery
Eustachian tube function normal |
|
| ExclusionCriteria |
| Details |
Squamosal otitis media
Revision ear surgeries
Canal wall down mastoidectomies
Compromised immunity
Diabetes
Preoperative craniofacial pain
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine whether silastic sheet interpositioning has effect on reducing craniofacial pain secondary to harvesting of temporalis fascia in myringoplasty.
|
Days 7,15,70,90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate craniofacial pain following temporalis fascia grafting in myringoplasty
|
Day 7,15,70,90 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2026 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
v Patients who undergo myringoplasty accompanied by temporalis fascia harvest complain of craniofacial pain in the ipsilateral temporal area during mastication or even while resting, this may arise either from direct injury to temporalis muscle or from post operative adhesions. Silastic is a known bio-inert and biofriendly material that has been extensively used as a barrier to prevent adhesion, particularly in the treatment of atelectatic tympanic membrane . This cost effective material can be conveniently cut and sized as per requirements. Therefore, in our study we are evaluating the antiadhesive effect of silastic sheet in reducing postoperative craniofacial pain after temporalis fascia harvest during myringoplasty.
|