Skip to content

A prospective, open, one slingle set of clincial trail to observe the tissue regeneration membrane repair soft tissue defect of safety and efficacy that in otolaryngology head and neck surgery.A clinical trial of repairing defects of nasal mucosa.

A prospective, open, one slingle set of clincial trail to observe the tissue regeneration membrane repair soft tissue defect of safety and efficacy that in otolaryngology head and neck surgery.A clinical trial of repairing defects of nasal mucosa.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-16008867
Enrollment
Unknown
Registered
2016-07-21
Start date
2016-07-25
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

defects of nasal mucosa

Interventions

treatment group:Covering tissue regeneration membrane

Sponsors

West China Hospital of Sichuan University
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. Not to participate in other clinical trails in three months before the start of the test ; 3. Indications: nasal sinus diseases (sinusitis and nasal polyps, benign tumor, nasal septum lesions, etc.) shall be line operation and cause the defects of nasal mucosa (wound maximum linear distance is greater than 1 cm); 4. After obtaining informed, voluntary and signed the informed consent. Note: for patients with bilateral, both sides are repaired, are evaluated.

Exclusion criteria

Exclusion criteria: 1. Severe liver and kidney dysfunction, metabolic syndrome, cardiovascular disease such as systemic disease cannot tolerate surgery; 2. During pregnancy or lactation women and patients with plan of pregnancy during the study period; 3. Allergy of collagen products; 4. The long-term use of immune inhibitor; 5. Can't tolerance of patients with general anesthesia; 6. With mental illness or mental abnormal; 7. Poor compliance, can't do with according to the visitor; 8 patients with surgical contraindication; 9. Other researchers determine does not comply with the conditions of patients.

Design outcomes

Primary

MeasureTime frame
Complete epithelial change rate;

Secondary

MeasureTime frame
Mucosal morphology change;Mucous membrane outcome 3 phase percentage;Subjective evaluations;

Countries

China

Contacts

Public ContactYongfang Wang

Yantai Zhenghai Bio-Tech Co., Ltd.

crawyf@163.com+86 15063856165

Outcome results

None listed

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