Clinical study on stent-free repair of acute perforation of tympanic membrane in moist and dry ear conditions

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078545

Enrollment

Unknown

Registered

2023-12-12

Start date

2024-01-06

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

traumatic tympanic membrane perfoation

Interventions

Normal saline treatment group:Normal saline therapy

Control group:none

Sterile distilled water group:Sterile distilled water

bFGF group:bFGF

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients were included in the clinical study who had perforated the tympanic membrane with a standard age greater than 18 years and a perforation greater than 1/2 of the tensor area of the tympanic membrane or a firecracker explosion injury.

Exclusion criteria

Exclusion criteria: Patients with middle ear infection or granulation tissue hyperplasia and suspected ossicular chain injury were excluded.

Design outcomes

Primary

Measure	Time frame
Healing time;closure rate;	—

Secondary

Measure	Time frame
infection rate;	—

Countries

China

Contacts

Public ContactZhengcai Lou

Yiwu Central Hospital

louzhengcai@163.com+86 137 3899 6868

Outcome results

None listed

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