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Prospective, multicenter, randomized, positive control, single blind, non inferior clinical trial for the efficacy and safety of high swelling and degradable hemostatic materials for post nasal operation

Prospective, multicenter, randomized, positive control, single blind, non inferior clinical trial for the efficacy and safety of high swelling and degradable hemostatic materials for post nasal operation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029792
Enrollment
Unknown
Registered
2020-02-14
Start date
2019-07-01
Completion date
Unknown
Last updated
2020-02-17

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

Conditions

Chronic rhino-sinusitis

Interventions

Two groups:high swelling and degradable hemostatic materials versus Control

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old; 2. The Lund Mackay score of single / bilateral chronic rhinosinusitis patients with or without nasal polyps was more than 2; 3. For the patients who need ess, the operation site is the first operation; 4. The blood coagulation function was normal before operation, and the platelet, Pt and APTT were within the normal value of hospital or judged by the researcher as abnormal without clinical significance; 5. Those who did not participate in other clinical trials within three months before the start of this trial; 6. Voluntarily participate in and sign the informed consent after obtaining full knowledge. Note: for patients with bilateral nasal cavity, use the same packing material on both sides, and randomly select one side as the observation side.

Exclusion criteria

Exclusion criteria: 1. Fungal sinusitis, allergic fungal sinusitis and tumor of nasal cavity and paranasal sinuses; 2. Patients who had used drugs affecting coagulation 2 weeks before operation; patients who had used hormone continuously in the past month, and patients who had used immunosuppressant for a long time; 3. Having mental illness or mental disorder; 4. Patients with surgical contraindications; 5. Pregnant women, lactating women, women of childbearing age who had positive urine HCG 48 hours before the test; male and female subjects did not take effective contraceptive measures, or planned to receive (give) pregnancy within 3 months after the start of the test; 6. Other patients who do not meet the inclusion criteria determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Postoperative success rate of hemostasis;

Secondary

MeasureTime frame
SNOT-20 at 1 week, 2 week and 4 week postoperation;

Countries

China

Contacts

Public ContactShixi Liu; Feng Liu

West China Hospital, Sichuan University

alexliufeng@vip.163.com+86 18628979607

Outcome results

None listed

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