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Prospective, randomized, controlled study of topical use of batroxase injection to prevent tympanic cavity adhension after tympanoplasty

Prospective, randomized, controlled study of topical use of batroxase injection to prevent tympanic cavity adhension after tympanoplasty

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043282
Enrollment
Unknown
Registered
2021-02-09
Start date
2021-02-18
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Chronic otitis media

Interventions

experimental group:Tympanum filling with gelatin sponge mixed with batroxase injection
control group:Tympanum filling with gelatin sponge mixed with dexamethasone injection

Sponsors

The First Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-60 years; 2) Consistent with the diagnosis of chronic suppurative otitis media or cholestatoma of the middle ear, intraoperative mucosal defect or lesion of the lateral wall of the inner tympanic chamber was confirmed; 3) stapes or stapes floor (or processing) good mobility, type II or type III tympanoplasty. 4) The result of pure tone audiometry was conductive hearing loss or mixed hearing loss (mean bone conductance = 30dB.

Exclusion criteria

Exclusion criteria: 1) A history of ear surgery or trauma; 2) Patients undergoing other types of tympanoplasty, such as upper tympanoplasty and open tympanoplasty; 3) congenital diseases that affect middle ear function such as cleft palate; 4) Preoperative fibrinogen was <1.0g/L; 5) Those who cannot recheck as required.

Design outcomes

Primary

MeasureTime frame
typanic canvity adhension;Tympanic membrane healed;hearing improvement;

Countries

China

Contacts

Public ContactChen yang
chendoc@fmmu.edu.cn+86 13991900675

Outcome results

None listed

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