Skip to content

Clinical efficacy observation of recombinant human basic fibroblast growth factor for chronic simple tympanic membrane perforation

Clinical efficacy observation of recombinant human basic fibroblast growth factor for chronic simple tympanic membrane perforation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078299
Enrollment
Unknown
Registered
2023-12-04
Start date
2023-12-15
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Chronic simple tympanic membrane perforation

Interventions

Endoscopic application of growth factor in tympanic membrane repair surgery group:NA

Sponsors

Beijing Pinggu District Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Acute traumatic tympanic membrane perforation that has not healed for more than 3 months;(2) Chronic otitis media (simple) in a stationary phase (dry ears for more than 3 months);(3) Mastoid CT examination shows complete ossicular chain;(4) Pure tone audiometry indicates conductive hearing loss.(5) Comply with medication and surgical indications and sign an informed consent form;

Exclusion criteria

Exclusion criteria: (1) Uncontrolled otitis media;(2) CT scan of the mastoid process indicates the presence of cholesteatoma, granulation, pus, and incomplete ossicular chain in the tympanic cavity, sinus, and mastoid process;(3) Narrowing of the external auditory canal;(4) Individuals with severe dysfunction of organs such as heart, liver, and kidney, as well as allergies to Gaifu;

Design outcomes

Primary

MeasureTime frame
Tympanic membrane healing rate;Hearing condition;

Secondary

MeasureTime frame
Anxiety, pain, and quality of life scores;

Countries

China

Contacts

Public ContactLiu Weijiao

Beijing Pinggu District Hospital

13683366043@163.com+86 130 7012 0102

Outcome results

None listed

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