| CTRI Number |
CTRI/2013/03/003518 [Registered on: 26/03/2013] Trial Registered Retrospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study outcomes of perioperative versus extended antimicrobial usage in tympanomastoid surgery for long standing middle ear diseases.
|
|
Scientific Title of Study
|
Comparing outcomes in perioperative only versus extended antimicrobial usage in tympanomastoid surgery for chronic otitis media: A randomized controlled trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1130-5168 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijay G Bidkar |
| Designation |
Assistant Professor |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
| Address |
211 Shreyas Block
SDM STAFF Quatrs
Sattur
Dharwad
Karnataka
Department of ENT
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
DHARWAD
KARNATAKA
Dharwad
KARNATAKA
580009
India |
| Phone |
919620886857 |
| Fax |
|
| Email |
vijay20dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay G Bidkar |
| Designation |
Assistant Professor |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
| Address |
211 Shreyas Block
SDM STAFF Quatrs
Sattur
Dharwad
Karnataka
Department of ENT
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
DHARWAD
KARNATAKA
Dharwad
KARNATAKA
580009
India |
| Phone |
919620886857 |
| Fax |
|
| Email |
vijay20dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijay G Bidkar |
| Designation |
Assistant Professor |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
| Address |
211 Shreyas Block
SDM STAFF Quatrs
Sattur
Dharwad
Karnataka
Department of ENT
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
DHARWAD
KARNATAKA
Dharwad
KARNATAKA
580009
India |
| Phone |
919620886857 |
| Fax |
|
| Email |
vijay20dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ENT |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
DHARWAD |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ashok Naik |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
DHARWAD
KARNATAKA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR VIJAY BIDKAR |
DEPARTMENT OF ENT |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
Dharwad
KARNATAKA |
9620886857
vijay20dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ACTIVE AND INACTIVE MUCOSAL DISEASE CHRONIC OTITIS MEDIA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Only perioperative antimicrobial prophylaxis for 24 hrs |
Intravenous Cefuroxime axetil 1.5 Gram preoperative loading dose given 30 minutes before incision as surgical antimicrobial prophylaxis followed by 750 mg of Cefuroxime axetil 12th hourly till 24 hours of postoperative period. |
| Comparator Agent |
Perioperative antimicrobial prophylaxis for 24 hrs and extended antimicrobial for 8 days |
Intravenous Cefuroxime axetil 1.5 Gram preoperative loading dose given 30 minutes before incision as surgical antimicrobial prophylaxis followed by 750 mg of Cefuroxime axetil 12th hourly till 24 hours of postoperative period. Active control group perioperative antimicrobial prophylaxis after 24 hours is followed by oral Cefixime 200mg 12th hourly for 8 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Active and inactive mucosal chronic otitis media
|
|
| ExclusionCriteria |
| Details |
Squamosal chronic otitis media,Revision tympanomastoid surgery,Ossicular discontinuity requiring reconstruction, tympanosclerosis, Diabetes mellitus other systemic disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Wound infection;Discharge from ear canal; Graft failure; adverse reaction to drug; Length of Hospital stay; revision due to failure
|
All the primary outcomes assessed individually at 1st, 2nd and 3rd week postoperatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Otoendoscopic examination |
1 month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "83"
Final Enrollment numbers achieved (India)="83" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2012 |
| Date of Study Completion (India) |
30/05/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/05/2014 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Bidkar VG, Jalisatigi RR, Naik AS, Shanbag RD, Siddappa R, Sharma PV, Hegde HV. Perioperative only versus extended antimicrobial usage in tympanomastoid surgery: a randomized trial. Laryngoscope. 2014 Jun;124(6):1459-63. doi: 10.1002/lary.24544. Epub 2014 Jan 15. PMID: 24307502. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized, double blind, parallel group, active controlled trial comparing outcomes in perioperative only versus extended antimicrobial usage in tympanomastoid surgery for active and inactive mucosal chronic otitis media that will be conducted at tertiary referal center ; Department of ENT, SDM College of Medical Sciences and Hospital, Dharwad, Karantaka, India. The primary outcome measure will assess various parameters of infection leading surgical site infection and graft failure (re perforation) requiring revision surgery. Hence judicious and responsible antimicrobial policy can be practiced for these type of surgeries by otolaryngologists |