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Randomized Controlled Trial of Middle Ear Irrigation with Povidone Iodine during Tympanoplasty: A Superiority Study on preventing surgical site infection

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075623
Enrollment
Unknown
Registered
2023-09-11
Start date
2023-09-11
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Surgical site infection after 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

Sponsors

EENT Hospital of Fudan University
Lead Sponsor

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

MeasureTime frame
The development of surgical site infection within 30 days after tympanoplasty;—

Secondary

MeasureTime frame
Time of postoperative surgical site infection occurrence;rate of graft failure ;—

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