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A clinical trial to study outcomes of perioperative versus extended antimicrobial usage in tympanomastoid surgery for long standing middle ear diseases.

Comparing outcomes in perioperative only versus extended antimicrobial usage in tympanomastoid surgery for chronic otitis media: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/03/003518
Enrollment
70
Registered
2013-03-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ACTIVE AND INACTIVE MUCOSAL DISEASE CHRONIC OTITIS MEDIA

Interventions

Intervention1: Only perioperative antimicrobial prophylaxis for 24 hrs: Intravenous Cefuroxime axetil 1.5 Gram preoperative loading dose given 30 minutes before incision as surgical antimicrobial prop

Sponsors

DEPARTMENT OF ENT
Lead Sponsor
Dr Ashok Naik
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Active and inactive mucosal chronic otitis media

Exclusion criteria

Exclusion criteria: Squamosal chronic otitis media,Revision tympanomastoid surgery,Ossicular discontinuity requiring reconstruction, tympanosclerosis, Diabetes mellitus other systemic disorder.

Design outcomes

Primary

MeasureTime frame
Wound infection;Discharge from ear canal; Graft failure; adverse reaction to drug; Length of Hospital stay; revision due to failure Timepoint: All the primary outcomes assessed individually at 1st, 2nd and 3rd week postoperatively—

Secondary

MeasureTime frame
Otoendoscopic examinationTimepoint: 1 month—

Countries

India

Contacts

Public ContactVijay G Bidkar

SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL

vijay20dr@gmail.com919620886857

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026