| CTRI Number |
CTRI/2026/01/101780 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Fat Graft Tympanic Membrane Closure With and Without 30% Trichloroacetic Acid |
|
Scientific Title of Study
|
Evaluating the Effectiveness of Fat Graft with 30 % Trichloroacetic Acid in comparison to conventional Tympanic Membrane Closure with Fat Graft alone in patients undergoing Myringoplasty : A Single blinded Randomized Controlled Trial |
| Trial Acronym |
FAT-TCA Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sachin Vejella |
| Designation |
POST GRADUATE |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
OPD No 9,Department of ENT,
Aarupadai Veedu Medical College and Hospital,bahour,kirumampakkam, puducherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
7702498152 |
| Fax |
|
| Email |
sacjoker579@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Mukul Bage |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
OPD NO 9, Department of ENT,
Aarupadai Veedu Medical College and Hospital,
bahour,kirumampakkam,puducherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9443292716 |
| Fax |
|
| Email |
atulbage25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Vejella |
| Designation |
POST GRADUATE |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
OPD No 9, Department of ENT,
Aarupadai Veedu Medical College and Hospital,bahour,kirumampakkam,puducherry,607403
Pondicherry
PONDICHERRY
607403
India |
| Phone |
7702498152 |
| Fax |
|
| Email |
sacjoker579@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sachin Vejella |
| Address |
OPD No 9, Department of ENT,
Aarupadai Veedu medical college, kirumampakkam, pondicherry |
| 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 Sachin Vejella |
Aarupadai Veedu Medical College and Hospital |
OPD No9, Department of ENT, Aarupadai Veedu Medical College and Hospital,bahour,kirumampakkam,puducherry,607403
Pondicherry
PONDICHERRY |
7702498152
sacjoker579@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H728||Other perforations of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coventional Fat plug myringoplasty |
Evaluating the Effectiveness of conventional Tympanic Membrane Closure with Fat Graft alone in patients undergoing Myringoplasty |
| Intervention |
Using 30 % Trichloroacetic Acid with fat graft |
Evaluating the Effectiveness of Fat Graft with 5ml of 30 % Trichloroacetic Acid applied locally when freshening the margins of Tympanic Membrane in patients undergoing Myringoplasty |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Small Sized Central Perforations
Small Sized Traumatic Perforations
No active discharge for atleast 6 weeks |
|
| ExclusionCriteria |
| Details |
Marginal or Large Central Perforations
Ossicular Chain Pathology
Immunocompromised or Diabetic Patients
Previous Ear Surgeries |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Graft Uptake |
At 3 weeks, 6 weeks and 12 weeks post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in hearing, complications and patient satisfaction |
At 3 weeks, 6 weeks and 12 weeks post surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="0"
Months="10"
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
|
While fat plug myringoplasty is a successful Opd based procedure for small TM perforations, success rates can be influenced by epithelial migration and healing. TCA , a chemical cauterizing agent, promotess healing by stimulating local inflammation and epithelial proliferation. Combining TCA and fat grafting may synergistically improve perforation closure rates. Establishing evidence through a randomized controlled trial can help standardize and improve clinical protocols, especially in resource limited settings. |