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Multi-center clinical study on repair of acute perforation of tympanic membrane in moist and dry environment

Multi-center clinical study on repair of acute perforation of tympanic membrane in moist and dry environment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084582
Enrollment
Unknown
Registered
2024-05-21
Start date
2024-05-21
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

acute tympanic membrane perforation

Interventions

First stage-Normal saline treatment group:0.9% saline was administered by ear drops through the external ear canal and applied locally to the surface of the tympanic membrane, twice a day, 2 drops per
First stage-control group:Follow-up observation, no treatment.
Second stage-Ofloxacin ear drops treatment group:Ofloxacin ear drop was administered by ear drops through the external ear canal and applied locally to the surface of the tympanic membrane, twice a da
Second stage-Recombinant bovine basic fibroblast growth factor eye drops treatment group:Recombinant bovine basic fibroblast growth factor eye drops (specification: 21000IU/5ml/ bottle) was administer
Second stage-Normal saline treatment group:0.9% saline was administered by ear drops through the external ear canal and applied locally to the surface of the tympanic membrane, twice a day, 2 drops pe

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age greater than 16 years old; 2. Tympanic membrane perforation larger than 1/4 of the area of the pars tensa; 3. Perforation duration less than 72 hours; 4. Air-bone gap <30 dB.

Exclusion criteria

Exclusion criteria: 1. Middle ear infection; 2. Granulation tissue proliferation in the middle ear; 3. Damage to the ossicular chain; 4. Sensorineural hearing loss caused by trauma-induced tympanic membrane perforation; 5. Individuals with Eustachian tube dysfunction; 6. Special populations such as pregnant women.

Design outcomes

Primary

MeasureTime frame
The healing of the eardrum;

Secondary

MeasureTime frame
Hearing improvement;

Countries

China

Contacts

Public ContactZhengnong Chen

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

jassey@126.com+86 189 3017 3986

Outcome results

None listed

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