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A clinical control study on external auditory canal packing with Shengji Yuhong collagen after tympanic membrane repair

A clinical control study on external auditory canal packing with Shengji Yuhong collagen after tympanic membrane repair to promote tympanic membrane angiogenesis and epithelization and improve inner ear damage

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062946
Enrollment
Unknown
Registered
2022-08-24
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Tympanic membrane perforation

Interventions

Control group:Tympanic membrane repair under Otoendoscope under general anesthesia
Treatment group:Tympanic membrane repair under Otoendoscope under general anesthesia+collagen tamponade of external auditory meatus
Treatment group:Tympanic membrane repair under Otoendoscope under general anesthesia+Shengji Yuhong collagen tamponade of external auditory meatus

Sponsors

Jiangsu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with tympanic membrane perforation (ICD10H72) and tympanic membrane repair (cartilage perichondrium tympanic membrane repair under ear endoscope under general anesthesia / fat plug tympanic membrane repair under ear endoscope under general anesthesia). 2. Patients aged between 18 and 70 years old, regardless of gender. 3. The clinical symptoms of traditional Chinese medicine are Qi deficiency and blood stasis syndrome. 4. The heart, liver and kidney functions are basically normal. 5. No history of other malignant tumors. 6. Informed consent, voluntary test. The process of obtaining informed consent complies with the provisions of GCP.

Exclusion criteria

Exclusion criteria: 1. Patients with marginal perforation, subtotal or total perforation, revision cases, cholesteatoma, any ossicular chain abnormality and fungal otitis externa. 2. Those who use steroid hormones to inhibit inflammatory response. 3. Poor cooperation or previous mental history. 4. Be allergic to multiple drugs or have a history of drug abuse. 5. Patients who are participating in clinical trials of other drugs. 6. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Perforation healing rate;Graft angiogenesis score;Graft epithelialization score;Interleukin;CRP;Angiogenesis related factors;VEGF;Electroaudiometry level;routine blood test;urinalysis;Liver and kidney function;Incidence of complications (more serious sensorineural hearing loss, tinnitus, infection, tympanic edema, taste changes, facial paralysis, dizziness);—

Countries

China

Contacts

Public ContactZhiyuan Zhu
260308@njucm.edu.cn+8617361972747

Outcome results

None listed

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