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The effect of local ciprofloxacin versus betamethasone in tympanoplasty

the effect of local ciprofloxacin drop on graft success rate and post operation infection in tympanoplasty

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200314046773N1
Enrollment
140
Registered
2020-05-22
Start date
2019-04-21
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

Tympanic membrane perforation. Perforation of tympanic membrane

Interventions

Intervention 1: Intervention group: The patients underwent tympanoplasty. Before placement of Gel foam into the middle ear, it got wet with ciprofloxacin drop (sina darou, Tehran, Iran). All patients

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Tympanoplasty operation for repair of tympanic membrane perforation Age between 18 and 60 years old perforation size more than 50% of tympanic membrane

Exclusion criteria

Exclusion criteria: Simultaneous mastoidectomy Diabetes mellitus History of immunodeficiency Chronic kidney disease History of previous surgery on each ear smoking intra-operative cholesteatoma, granulation tissue, tympanosclerotic plaque and ossicular erosion

Design outcomes

Primary

MeasureTime frame
Complete healing of tympanic membrane in microscopic examination. Timepoint: Microscopic examination of ear 3 weeks, 6 weeks, 3 months and 6 months after tympanoplasty. Method of measurement: Microscopic otoscopy by an otologist.;Post operative infection. Timepoint: Microscopic examination of ear 3 weeks, 6 weeks, 3 months and 6 months after tympanoplasty. Method of measurement: Microscopic otoscopy by an otologist.

Secondary

MeasureTime frame
Air- bone gap (ABG) audiometric test. Timepoint: Before tympanoplasty operation and 6 months after operation. Method of measurement: Audiometer.;Speech reception thresholds (SRT) audiometric test. Timepoint: Before tympanoplasty operation and 6 months after operation. Method of measurement: Audiometer.;Speech discrimination score (SDS) audiometric test. Timepoint: Before tympanoplasty operation and 6 months after operation. Method of measurement: Audiometer.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactOmid Zargarani

Shiraz University of Medical Sciences

o.zargerani@gmail.com+98 71 3629 1470

Outcome results

None listed

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