Randomized Controlled Trial of Middle Ear Irrigation with Povidone Iodine during Tympanoplasty: A Non-Inferiority Study on Postoperative Hearing Levels

A randomized controlled study of using povidone iodine to rinse the middle ear during tympanoplasty

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075252

Enrollment

Unknown

Registered

2023-08-30

Start date

2023-09-01

Completion date

Unknown

Last updated

2023-09-04

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

Conditions

Postoperative hearing level of tympanoplasty

Interventions

Intervention Group:Irrigate the whole middle ear with 5% Povidone-iodine solution and keep in the middle ear for 30 seconds, soak the gelatin sponge with 5% Povidone-iodine solution when tamping midd

Placebo Group:Irrigate the whole middle ear with Normal Saline and keep in the middle ear for 30 seconds, soak the gelatin sponge with Normal Saline when tamping middle ear

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients scheduled for tympanoplasty surgery due to chronic otitis media Clean middle ear Age 18 to75 years Able to provide informed consent Able to conduct postoperative follow-up

Exclusion criteria

Exclusion criteria: Pregnant or breast feeding Allergic to Povidone Iodine Thyroid disease which need to control iodine intake Immunosuppressive therapy or immunodeficiency Purulent secretion in middle ear With preoperative vertigo Any evidence of perilymphatic fistula

Design outcomes

Primary

Measure	Time frame
The pure tone average of bone conduction at 30 days after tympanoplasty;	—

Secondary

Measure	Time frame
The pure tone average of air conduction at 30 days after tympanoplasty;The air bone gap at 30 days after tympanoplasty;Bone conduction hearing thresholds of various frequencies at 30 days after tympanoplasty;Air conduction hearing thresholds of various frequencies at 30 days after tympanoplasty;Percentage of patients experiencing vertigo on the first day after tympanoplasty;The percentage difference between patients with tinnitus 30 days after tympanoplasty and patients with preoperative tinnitus;The THI average score of patients experiencing tinnitus 30 days after tympanoplasty;	—

Measure

Time frame

The pure tone average of air conduction at 30 days after tympanoplasty;The air bone gap at 30 days after tympanoplasty;Bone conduction hearing thresholds of various frequencies at 30 days after tympanoplasty;Air conduction hearing thresholds of various frequencies at 30 days after tympanoplasty;Percentage of patients experiencing vertigo on the first day after tympanoplasty;The percentage difference between patients with tinnitus 30 days after tympanoplasty and patients with preoperative tinnitus;The THI average score of patients experiencing tinnitus 30 days after tympanoplasty;

—

Countries

China

Contacts

Public ContactZhen Gao

EENT Hospital of Fudan University

gaozhenfd@sina.com+86 134 8245 3676

Outcome results

None listed

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