| CTRI Number |
CTRI/2018/08/015343 [Registered on: 14/08/2018] Trial Registered Prospectively |
| Last Modified On: |
13/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to compare the Effect of closing the Hole in the Ear Drum using cartilage and fascia. |
|
Scientific Title of Study
|
The Comparison of Tympnoplasty with Temporalis Fascia Graft Versus Cartilage Composite Graft A 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 |
Dr Shruthi Sreekumar |
| Designation |
MS PG Student |
| Affiliation |
SRM General Hospital SRM University |
| Address |
Department of ENT, SRM General Hospital SRM University, Kattankulathur, 603203, Kancheepuram District,INDIA
Chennai
TAMIL NADU
603203
India |
| Phone |
09962020252 |
| Fax |
|
| Email |
shruthi_sreekumar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P K Purushothaman |
| Designation |
HOD & Professor |
| Affiliation |
SRM General Hospital SRM University |
| Address |
Department of ENT, SRM General Hospital SRM University, Kattankulathur, 603203, Kancheepuram District, INDIA
Kancheepuram
TAMIL NADU
603202
India |
| Phone |
9840723243 |
| Fax |
|
| Email |
entpurush@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CRK Balaji |
| Designation |
Associate Professor |
| Affiliation |
SRM General Hospital SRM University |
| Address |
Department Of ENT, SRM General Hospital SRM University, Kattankulathur, 603203, Kancheepuram District, INDIA
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884187257 |
| Fax |
|
| Email |
crkbalaji12@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College & research centre , kattangulathur, kancheepuram dist , tamilnadu, 603203 |
|
|
Primary Sponsor
|
| Name |
Dr Shruthi Sreekumar |
| Address |
SRM Medical College & research centre , kattangulathur, kancheepuram dist , tamilnadu, 603203 |
| 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 |
| Shruthi Sreekumar |
SRM Medical College And Research Centre |
Department of ENT,SRM Medical College And Research Centre,Kattankulathur,Kancheepuram dist. 603203
Kancheepuram
TAMIL NADU |
9962020252
shruthi_sreekumar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College & research centre institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H663||Other chronic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Composite Cartilage Graft versus Temporalis Fascia Graft usage in Tympanoplasty |
Composite cartilage graft harvested under sterile aseptic Precautions from the Tragus or Concha of the same patient used instead of the conventional Temporalis Fascia graft , and placed lateral to handle of malleus. |
| Intervention |
Tympanoplasty using Cartilage Composite Graft |
All patients with Chronic Supporative Otitis Media mucosal inactive disease (central or subtotal perforation with dry ear )with no discharge for atleast 6 to 8 weeks will be randomised into 2 groups of which one group will undergo tympanoplasty using conventional temporalis fascia graft and another group wil undergo tympanoplasty using cartilage composite graft.
All patients will be under IV antibiotic cover post operatively.sutures will be removed on the seventh postoperative day and given oral antibiotics and antihistamine.patient will be on regular follow up every 15 days for 3 months.
Otoendoscopic examination will be done post operatively to evaluate the graft take up post operatively as well as to look for garft failure and reinfection. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patients with anterior perforation,eustitian tube dysfunction,recurrent perforation
2.patients who are primary tympanoplasty cases with subtotal or large perforation.
3.patients diagnosed with CSOM Mucosal Type
4.patients with atleast 3 weeks dry period. |
|
| ExclusionCriteria |
| Details |
1.patients with active infection.
2.Unsafe type of CSOM
3.patients having discharge ear.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative outcomes assesed
1)Epithelialisation Of Graft
2)Graft Displacement
3)Rinnes Test
4)Webbers Test
5)Perforation Closure
6)Overall Outcome |
Post operative assesments on
1.8 th day
2.15 th day
3.30 th day
4.45 th day
5.60 th day
6.75 th day
7.90 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hearing improvement which is assessed by Pure Tone Audiometry |
60 th Post Operative Day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/08/2018 |
| 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
|
After the completion of the trial the trial will be published in peer reviewed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To do a Prospective study in the department of ENT , SRM Medical College Hospital And
Research Centre , Kattankulathur to evalute the effectiveness of usage of
cartilage composite graft in patients undergoing tympanoplasty from aug 2018 to
jan 2020 with follow up upto 3 months.Patients will be randomised into 2 groups
: case group with 30 patients who will receive Partilage composite graft and
control group who will include 30 patients who will receive temporalus fascia
graft.
|