| CTRI Number |
CTRI/2025/03/081932 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Silastic Sheets Help in Middle Ear Surgery: Better Healing and Improved Hearing |
|
Scientific Title of Study
|
Outcomes of Surgical Management of Chronic Otitis Media with Silastic Sheet Graft Reinforcement - A Randomised 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 |
Dr Sharika Sakunthala A |
| Designation |
MS ENT Post graduate |
| Affiliation |
SRM Medical College Hospital And Research Centre |
| Address |
SRM Medical College Hospital And Research Centre, Department of ENT, SRM Nagar, Potheri, Kattankulathur, Chengalpattu,
Chennai
Tamil Nadu 603203.
Chennai
TAMIL NADU
603203
India |
| Phone |
8220530343 |
| Fax |
|
| Email |
sharikashakunthala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Malarvizhi R |
| Designation |
MS ENT |
| Affiliation |
Srm medical college hospital and research centre |
| Address |
SRM Medical College Hospital And Research Centre, Department of ENT, SRM Nagar, Potheri, Kattankulathur, Chengalpattu,
Chennai
Tamil Nadu 603203.
Chennai
TAMIL NADU
603203
India |
| Phone |
9444753019 |
| Fax |
|
| Email |
malarvir@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sharika Sakunthala A |
| Designation |
MS ENT Post graduate |
| Affiliation |
Srm medical college hospital and research centre |
| Address |
SRM Medical College Hospital And Research Centre, Department of ENT, SRM Nagar, Potheri, Kattankulathur, Chengalpattu,
Chennai
Tamil Nadu 603203.
Chennai
TAMIL NADU
603203
India |
| Phone |
8220530343 |
| Fax |
|
| Email |
sharikashakunthala@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical college hospital and research centre, SRM nagar, Potheri, Kattankulathur, Chengalpattu -603203 |
|
|
Primary Sponsor
|
| Name |
Dr Sharika Sakunthala A |
| Address |
SRM Medical College Hospital And Research
Centre, SRM Nagar, Potheri, Chengalpattu,
Tamil Nadu 603203. |
| 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 |
| Dr Sharika Sakunthala A |
Srm medical college hospital and research centre |
Department of ENT, srm medical college hospital, Potheri, kattankulathur
Chennai- 603203
Chennai
TAMIL NADU |
8220530343
sharikashakunthala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, srm medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H720||Central perforation of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Middle ear surgeries performed using Temporalis fascia graft or tragal cartilage |
Group - B: Middle ear surgeries performed using either temporalis fascia graft or tragal cartilage as graft materia to cover the perforation of the tympanic membrane and hearing and graft uptake is assessed one and two months postoperatively. |
| Intervention |
Silastic sheet ( decisheet silicone sheet ) insertion in middle ear surgeries |
Group A :Silastic sheet of appropriate size would be placed in the medial wall of tympanic cavity during middle ear surgeries using underlay technique. Post operative hearing and graft uptake is assessed one and two months postoperatively |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Patients suffering from chronic otitis media
-Patients who offered informed and written consent to undergo the surgical procedure |
|
| ExclusionCriteria |
| Details |
-Presence of middle ear mucosal edema
-Presence of ossicular necrosis
-Cholesteatoma
-Granulation tissue tympanosclerosis and
-Poor eustachian tube function. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Hearing outcome
2. Graft uptake |
1. 1 month, 2 months
2. 1 month, 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| At the end of follow-up period, to assess any complications like purulent ear discharge |
One and two months post operatively to assess any complications that could arise |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
17/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/11/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is a randomized controlled trial, open blinded, studying the effect of Silastic sheet in middle ear surgeries assessing post operative hearing improvement and graft uptake in comparison to temporalis fascia graft. This study will be done for a period of 12 months and all patients from the inclusion criteria would be included in the study and randomised into two groups- Group A and Group B. In Group A, Silastic sheet would be used as a graft material. In Group B, Temporalis fascia graft would be used. Post operatively, Hearing improvement and Graft uptake would be assessed comparing the two groups. |