| CTRI Number |
CTRI/2019/03/017916 [Registered on: 05/03/2019] Trial Registered Retrospectively |
| Last Modified On: |
06/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
HOW TO HAZEN THE HEALING OF MASTOID CAVITY AFTER SURGERY. |
|
Scientific Title of Study
|
TO STUDY THE EFFECT OF FASCIA WITH FREE SKIN GRAFT ON THE HEALING OF MASTOID CAVITY OF CANAL WALL DOWN MASTOIDECTOMY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKSHATHA SHETTY M |
| Designation |
pg scholar |
| Affiliation |
karnataka institute of medical sciences |
| Address |
DEPARTMENT OF ENT,
KARNATKA INSTITUTE OF MEDICAL SCIENCES,
P.B ROAD , VIDYANAGAR , HUBLI.
Dakshina Kannada
KARNATAKA
580022
India |
| Phone |
9741526245 |
| Fax |
|
| Email |
akshathashettym@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KIRAN BONGALE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
karnataka institute of medical sciences |
| Address |
DEPARTMENT OF ENT,
KARNATKA INSTITUTE OF MEDICAL SCIENCES,
P.B ROAD , VIDYANAGAR , HUBLI.
Dharwad
KARNATAKA
580022
India |
| Phone |
9740751502 |
| Fax |
|
| Email |
kiranbongale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AKSHATHA SHETTY M |
| Designation |
PG SCHOLAR |
| Affiliation |
karnataka institute of medical sciences |
| Address |
DEPARTMENT OF ENT,
KARNATKA INSTITUTE OF MEDICAL SCIENCES,
P.B ROAD , VIDYANAGAR , HUBLI.
Dharwad
KARNATAKA
580022
India |
| Phone |
9741526245 |
| Fax |
|
| Email |
akshathashettym@gmail.com |
|
|
Source of Monetary or Material Support
|
| KARNATAKA INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
akshatha shetty m |
| Address |
akshatha shetty,
MS ENT,
DEPARTMENT OF ENT,
KARNATAKA INSTITUTE OF MEDICAL SCIENCES, P.B ROAD,VIDYANAGAR,HUBBALLI
580022 |
| Type of Sponsor |
Other [] |
|
|
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 |
| AKSHATHA SHETTY M |
karnataka institute of medical sciences |
karnataka institute of medical sciences, P.B. road, vidyanaga, hubli.
580022
Dharwad
KARNATAKA |
9741526245
akshathashettym@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KARNATAKA INSTITUTEC OF MEDICAL SCIENCES , HUBLI ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CHRONIC OTITIS MEDIA WITH SQUAMOSAL DISEASE, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CANAL WALL DOWN MASTOIDECTOMY WITH FASCIA WITH FREE SKIN GRAFT. |
TO EVALUATE AND ASSESS THE EFFECT OF FASCIA WITH FREE SKIN GRAFT ON THE HEALING OF MASTOID CAVITY IN CANAL WALL DOWN MASTOIDECTOMY IN COMPARISON WITH THE CANAL WALL DOWN MASTOIDECTOMY WITHOUT SKIN GRAFT. |
| Comparator Agent |
CANAL WALL DOWN MASTOIDECTOMY WITHOUT FASCIA OR SKIN GRAFT. |
TO EVALUATE AND ASSESS THE EFFECT OF FASCIA WITH FREE SKIN GRAFT ON THE HEALING OF MASTOID CAVITY IN CANAL WALL DOWN MASTOIDECTOMY IN COMPARISON WITH THE CANAL WALL DOWN MASTOIDECTOMY WITHOUT SKIN GRAFT. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WITH CHRONIC OTITIS MEDIA WITH SQUAMOSAL DISEASE. |
|
| ExclusionCriteria |
| Details |
PATIENTS WITH CHRONIC OTITIS MEDIA WITH MUCOSAL DISEASE , WITH INTRACRANIAL COMPLICATION AND IMMUNOCOMPROMISED PATIENTS. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TIME TAKEN FOR HEALING OF THE MASTOID CAVITY, TYPE OF HEALING AND EPITHELIALIZATION |
TIME TAKEN FOR HEALING OF THE MASTOID CAVITY, TYPE OF HEALING AND EPITHELIALIZATION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REFUSAL TO BECOME DRY,FUNGAL INFECTION ,RECURRENCE OF CHOLESTEATOMA |
1 MONTH , 3 MONTH ,6 MONTH |
|
|
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)
|
04/12/2017 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Chronic otitis media is the long standing infection of the middle ear cleft characterised by ear discharge and permanent perforation of tympanic membrane.It is one of the prevalent ear disease in India.After canal wall down mastoidectomy it takes long time for cavity to heal and epithelialise. Post surgical cavity problems are challenge to manage . Early healing and epithelialization overcome these problems. Mastoid obliterration as a solution is both time consuming and expensive.Most of these techniques are irreversible in case of disease recurrence.This study aimed to drastically cut down the healing time of post mastoid cavity with simple irreversible technique(fascia with skin graft) by comparing it with the standard( no skin or fascia). |