| CTRI Number |
CTRI/2024/04/065134 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A prospective study to assess the effectiveness of hyaluronic acid in myringoplasty surgery |
|
Scientific Title of Study
|
EVALUATING THE EFFICACY OF HYALURONIC ACID IN MYRINGOPLASTY- A PROSPECTIVE CONTROLLED CLINICAL 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 Ajmal A |
| Designation |
Junior Resident |
| Affiliation |
Vinayaka Missions Medical College Hospital, Karaikal |
| Address |
Sumi manzil, House no-567
Athikkattukulangara, Palamel village, ward 11, Nooranad post office
Alappuzha
KERALA
690504
India |
| Phone |
9656088111 |
| Fax |
|
| Email |
ajmalayub1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Srinivasa |
| Designation |
Professor and Head of the Department |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE HOSPITAL, KARAIKAL |
| Address |
Otorhinolaryngology department,room no 177
VMMCH hospital,Kottucherry post office
Karaikal
PONDICHERRY
609609
India |
| Phone |
09842774997 |
| Fax |
|
| Email |
vemsrigeenan2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajmal A |
| Designation |
Junior Resident |
| Affiliation |
Vinayaka Missions Medical College Hospital, Karaikal |
| Address |
Sumi manzil, House no-567
Athikkattukulangara, Palamel village, ward 11, Nooranad post office
Alappuzha
KERALA
690504
India |
| Phone |
9656088111 |
| Fax |
|
| Email |
ajmalayub1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Medical College Hospital, Kottucherry post, Karaikal, Puducherry, pin 609609 |
|
|
Primary Sponsor
|
| Name |
Dr Ajmal A |
| Address |
Sumi manzil, Athikkattukulangara, P.O, Nooranad , Alappuzha district, Kerala, Pin 690504 |
| 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 |
| AJMAL A |
VINAYAKA MISSIONS MEDICAL COLLEGE HOSPITAL |
VINAYAKA MISSIONS MEDICAL COLLEGE HOSPITAL
Karaikal
PONDICHERRY |
9656088111
ajmalayub1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KEESHAKASAKUDIMEDU KOTUCHERRY P.O KARAIKAL PUDUCHERRY |
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 |
| Intervention |
Evaluating the efficacy of using Hyaluronic Acid in Myringoplasty surgery |
1 ml of Hyaluronic acid available as Sodium Hyaluronate 20mg/2ml is applied one time topically along with absorbable gelatin sponge bits under strict aseptic precautions to pack the external auditory canal after placing temporalis facia graft in Myringoplasty surgery. which is followed by placing antibiotic wick in external ear canal. Patient is evaluated on 2nd post operative week, after removal of ear wick under otomicroscope, to see if graft acceptance is better or not. |
| Comparator Agent |
Standard procedure of Myringoplasty surgery |
Classically, following temporalis fascia graft placement in Myringoplasty surgery, external auditory canal is packed with absorbable gelatin sponge bits to support the graft and ear canal kept with antibiotic wick. Ear wick is removed 1-2 weeks following surgery to see the graft acceptance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Dry ears, with out any ear discharge for atleast 6 weeks
2. No Tympanic membrane retraction pocket and cholesteatoma
3. AB (air-bone) gap less than 35 decibels
4. Normal ear ossicular function
5. Normal eustachian tube function
6. No immunodeficient conditions |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Better acceptance of graft in Myringoplasty and improvement of hearing |
2nd week, 3rd week, 2nd month and 3rd month post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Faster graft healing time in Myringoplasty. |
10th, 15th & 20th post operative days |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 2 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Studies have been done to find out efficacy of Hyaluronic acid as an adjuvant in fat graft myringoplasty and as topical use to enhance healing of small tympanic perforations, theresults are excellent. But studies on hyaluronic acid as an adjuvant in myringoplasty of larger perforations is comparatively fewer in number. Hence more research is needed on this topic. |