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A multicenter, randomized, open clincal trial that to evaluate the effect and safety of tissue regeneration membrane promote dry ear early.

A multicenter, randomized, open clincal trial that to evaluate the effect and safety of tissue regeneration membrane promote dry ear early.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16009425
Enrollment
Unknown
Registered
2016-10-15
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Chronic suppurative otitis media and middle ear cholesteatoma

Interventions

treatment group:Bone surface covering tissue regeneration membrane
control group:conventional surgical treatment

Sponsors

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18-70 years; 2. The patient with chronic suppurative otitis media and/or middle ear cholesteatoma; 3. The patient need to open mastoidotympanectomy; 4. The patient hadn't to participate in other clinical trial in three months before the start; 5. After obtaining informed, voluntary and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient need to shrinkage cavity mastoidotympanectomy; 2. Allergy of collagen products; 3. The patient with mental illness or mental abnormal; 4. The patient is suffering from acute or chronic respiratory infection; 5. The patient with severe liver and kidney dysfunction or metabolic syndrome or serious systemic diseases such as malignant tumor; 6. During pregnancy or breastfeeding women or plan in the three months of pregnancy patient; 7. Nearly a month general continuous use hormone; 8. Long-term use of immune inhibitor; 9. Patient with diabetes; 10. Patient with surgical contraindication; 11. Other researchers determine does not comply with the conditions of patients.

Design outcomes

Primary

MeasureTime frame
dry ear rate;

Secondary

MeasureTime frame
dry ear rate;Air-bone gap that Postoperative and preoperative differential;time of surgery;number of dressing change;

Countries

China

Contacts

Public ContactZhiqiang Gao

Chinese Academy of Medical Sciences and Peking Union Medical College Hospital

tallzq2012@sina.com+86 010 69156301

Outcome results

None listed

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